[{"_1":2,"_72":-5,"_73":-5},"loaderData",{"_3":4,"_12":13},"root",{"_5":-5,"_6":7,"_8":9,"_10":11},"user","recaptchaSiteKey","6Ler9Q4rAAAAAIntb4jBhAbPRXMJSQVneAzxg5M8","sentryTrace","f0006a50c3be256ae149c9a5343aa22d-5ea4dc8486b9aeac-0","sentryBaggage","sentry-environment=production,sentry-public_key=fbef35ac88c344bffa6f98009cf3736c,sentry-trace_id=f0006a50c3be256ae149c9a5343aa22d,sentry-org_id=4505908219871232,sentry-sampled=false,sentry-sample_rand=0.6182495705845359,sentry-sample_rate=0.5","routes/domain.$domainId",{"_14":15,"_68":69,"_5":-5,"_70":71},"domain",{"_16":17,"_14":18,"_19":20,"_21":22,"_23":24,"_25":26,"_27":28,"_29":-5,"_30":-5,"_31":-5,"_32":33,"_43":44,"_49":50,"_66":67},"id","cmhdm5oum0089jv02gxcdb57a","www.tagrissohcp.com","screenshotPath","sites/www.tagrissohcp.com/screenshot.jpg","htmlPath","sites/www.tagrissohcp.com/index.html","metaDescription","Learn about TAGRISSO® (osimertinib), a targeted therapy for patients with certain types of EGFRm non-small cell lung cancer (NSCLC).","importantText","TAGRISSO for Resectable, Metastatic, and Unresectable EGFRm NSCLC | For HCPs \n\n[skip navigation](#skiptomaincontent)\n\nToggle navigation\n\n[![TAGRISSO® (osimertinib) Logo](/content/dam/open-digital/tagrisso-hcp/us/en/global/tagrisso-logo.png)](/)\n\n[SELECT AN INDICATION](#)\n\n* **SELECT AN INDICATION**\n * [**RESECTABLE** \n EGFRm NSCLC ![](/content/dam/open-digital/tagrisso-hcp/us/en/global/Resectable-lung.svg)](/resectable/adaura.html) \n * [**LOCALLY ADVANCED \n UNRESECTABLE** \n EGFRm NSCLC FOLLOWING CRT ![](/content/dam/open-digital/tagrisso-hcp/us/en/global/u-lung-icon.svg)](/unresectable/laura.html) \n * [**METASTATIC** \n EGFRm NSCLC ![](/content/dam/open-digital/tagrisso-hcp/us/en/global/Metastatic-lung.svg)](/metastatic/flaura.html) \n * [**LOCALLY ADVANCED \n OR METASTATIC** \n EGFRm NSCLC ![](/content/dam/open-digital/tagrisso-hcp/us/en/global/Metastatic-lung.svg)](/metastatic/flaura2.html) \n\nTAGRISSO monotherapy ![toggle switch](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/toggleIndicator.svg) TAGRISSO + \nCT (pem/plat)\n\n* * *\n\n* [Important Safety Information](#isi-link-head)\n* [Prescribing Information](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1)\n* [For APPs & Nurse Teams](/nurses-and-apps.html)\n* [For Patients](https://www.tagrisso.com)\n* [AZ Medical Information Support](https://medicalinformation.astrazeneca-us.com/)\n* [Contact a Representative](/contact-a-representative.html)\n* [](https://www.youtube.com/channel/UCQ0-tofGVEVr_ttn_ATpyKw/videos)\n\n[![TAGRISSO® (osimertinib) Logo](/content/dam/open-digital/tagrisso-hcp/us/en/global/tagrisso-logo.png)](/)\n\n* [Important Safety Information](#isi)\n* [Prescribing Information](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1)\n\nToggle navigation\n\n* [Home](/)\n\n* [More Hide](#)\n \n\n* [About](/about.html)\n* [MOA](/moa.html)\n* [Support](/support.html)\n * [Financial support](/support.html#financial)\n * 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[Subgroups](/resectable/adaura/efficacy.html#subgroups)\n * [CNS DFS data](/resectable/adaura/efficacy.html#cns)\n * [ADAURA study design](/resectable/adaura/efficacy.html#adaura)\n * [Staging](/resectable/adaura/efficacy.html#staging)\n * [Patient identification](/resectable/adaura/efficacy.html#rethink-treatment)\n \n * [Safety](#)\n \n * [ADAURA adverse reactions](/resectable/adaura/safety-side-effects.html#adverse-reactions)\n * [Laboratory abnormalities](/resectable/adaura/safety-side-effects.html#laboratory-abnormalities)\n \n * [Surgeon](#)\n \n * [Disease recurrence](/resectable/adaura/surgeon.html#disease-recurrence)\n * [EGFR as driver](/resectable/adaura/surgeon.html#egfr-as-driver)\n * [DFS/OS data](/resectable/adaura/surgeon.html#dfs)\n * [Subgroup analysis](/resectable/adaura/surgeon.html#chemo)\n * [Safety](/resectable/adaura/surgeon.html#safety)\n * [Discuss, refer, test](/resectable/adaura/surgeon.html#discuss-refer-test)\n * [Referral 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treat](/unresectable/laura/efficacy.html#test-know-treat)\n * [TAGRISSO approvals](/unresectable/laura/efficacy.html#tagrisso-approvals)\n \n * [Safety](#)\n \n * [LAURA adverse reactions](/unresectable/laura/safety-side-effects.html#adaura-adverse-reactions)\n * [LAURA laboratory abnormalities](/unresectable/laura/safety-side-effects.html#laboratory-abnormalities)\n * [ILD/pneumonitis](/unresectable/laura/safety-side-effects.html#ild-section)\n \n * [Radiation Oncologists](#)\n \n * [Disease state](/unresectable/laura/rad-oncologists.html#metastases)\n * [TAGRISSO approvals](/unresectable/laura/rad-oncologists.html#tagrisso-approvals)\n * [PFS](/unresectable/laura/rad-oncologists.html#pfs)\n * [Subgroups](/unresectable/laura/rad-oncologists.html#subgroups)\n * [New lesion sites](/unresectable/laura/rad-oncologists.html#new-lesion-sites)\n * [Testing](/unresectable/laura/rad-oncologists.html#testing)\n * [Safety](/unresectable/laura/rad-oncologists.html#safety)\n \n * [Dosing](/unresectable/laura/dosing.html)\n * [MOA](/unresectable/laura/moa.html)\n * [Support](#)\n \n * [Financial support](/unresectable/laura/support.html#financial)\n * [HCP resources](/unresectable/laura/support.html#resources)\n \n* [**Metastatic** EGFRm NSCLC](/metastatic/flaura.html) show submenu for “Metastatic EGFRm NSCLC”\n * [NSCLC & Testing](#)\n \n * [Know the driver](/metastatic/flaura/testing.html#know-the-driver)\n * [Test everyone](/metastatic/flaura/testing.html#test-everyone)\n * [Confirm before treating](/metastatic/flaura/testing.html#confirm-before-treatment)\n * [How to test](/metastatic/flaura/testing.html#how-to-test)\n * [NCCN Guidelines](/metastatic/flaura/testing.html#nccn-guidelines)\n \n * [Efficacy](#)\n \n * [Overall survival](/metastatic/flaura/efficacy.html#overall-survival)\n * [PFS](/metastatic/flaura/efficacy.html#pfs)\n * [Subgroups](/metastatic/flaura/efficacy.html#efficacysubgroups)\n * [CNS data](/metastatic/flaura/efficacy.html#cns-data)\n * [FLAURA study design](/metastatic/flaura/efficacy.html#flaura)\n \n * [Safety](#)\n \n * [FLAURA adverse reactions](/metastatic/flaura/safety-side-effects.html#adverse-reactions)\n * [Laboratory abnormalities](/metastatic/flaura/safety-side-effects.html#laboratory-abnormalities)\n \n * [AURA3](/metastatic/aura.html)\n * [Dosing](/metastatic/flaura/dosing.html)\n * [Video](/metastatic/flaura/video-library.html)\n * [MOA](/metastatic/flaura/moa.html)\n * [Support](#)\n \n * [Financial support](/metastatic/flaura/support.html#financial-support)\n * [HCP resources](/metastatic/flaura/support.html#resources)\n \n* [**LOCALLY ADVANCED OR METASTATIC** EGFRm NSCLC](/metastatic/flaura2.html) show submenu for “Metastatic EGFRm NSCLC”\n * [NSCLC & Testing](#)\n \n * [Know the driver](/metastatic/flaura2/testing.html#know-the-driver)\n * [Test everyone](/metastatic/flaura2/testing.html#test-everyone)\n * [Confirm before treating](/metastatic/flaura2/testing.html#confirm-before-treatment)\n * [How to test](/metastatic/flaura2/testing.html#how-to-test)\n * [NCCN Guidelines](/metastatic/flaura2/testing.html#nccn-guidelines)\n * [Unmet need](/metastatic/flaura2/testing.html#unmet-need)\n \n * [Efficacy](#)\n \n * [PFS/OS results](/metastatic/flaura2/efficacy.html#pfs)\n * [Subgroups](/metastatic/flaura2/efficacy.html#subgroups)\n * [CNS data](/metastatic/flaura2/efficacy.html#additional-results)\n * [FLAURA2 study design](/metastatic/flaura2/efficacy.html#flaura-study-design)\n \n * [Safety](#)\n \n * [FLAURA2 adverse reactions](/metastatic/flaura2/safety-side-effects.html#flaura-adverse-reactions)\n * [Laboratory abnormalities](/metastatic/flaura2/safety-side-effects.html#laboratory-abnormalities)\n * [Additional results](/metastatic/flaura2/safety-side-effects.html#additional-results)\n \n * [Dosing](/metastatic/flaura2/dosing.html)\n * [Video](/metastatic/flaura2/video-library.html)\n * [MOA](/metastatic/flaura2/moa.html)\n * [Support](#)\n \n * [Financial support](/metastatic/flaura2/support.html#financial-support)\n * [HCP resources](/metastatic/flaura2/support.html#hcp)\n \n* [TAGRISSO Monotherapy](/metastatic/flaura.html) show submenu for “Metastatic EGFRm NSCLC”\n * [NSCLC & Testing](#)\n \n * [Know the driver](/metastatic/flaura/testing.html#know-the-driver)\n * [Test everyone](/metastatic/flaura/testing.html#test-everyone)\n * [Confirm before treating](/metastatic/flaura/testing.html#confirm-before-treatment)\n * [How to test](/metastatic/flaura/testing.html#how-to-test)\n * [NCCN Guidelines](/metastatic/flaura/testing.html#nccn-guidelines)\n \n * [Efficacy](#)\n \n * [Overall survival](/metastatic/flaura/efficacy.html#overall-survival)\n * [PFS](/metastatic/flaura/efficacy.html#pfs)\n * [Subgroups](/metastatic/flaura/efficacy.html#efficacysubgroups)\n * [CNS data](/metastatic/flaura/efficacy.html#cns-data)\n * [FLAURA study design](/metastatic/flaura/efficacy.html#flaura)\n \n * [Safety](#)\n \n * [FLAURA adverse reactions](/metastatic/flaura/safety-side-effects.html#adverse-reactions)\n * [Laboratory abnormalities](/metastatic/flaura/safety-side-effects.html#laboratory-abnormalities)\n \n * [AURA3](/metastatic/flaura/aura.html)\n * [Dosing](/metastatic/flaura/dosing.html)\n * [Video](/metastatic/flaura/video-library.html)\n * [MOA](/metastatic/flaura/moa.html)\n * [Support](#)\n \n * [Financial support](/metastatic/flaura/support.html#financial-support)\n * [HCP resources](/metastatic/flaura/support.html#hcp)\n \n* [TAGRISSO + CT (pem/plat)](/metastatic/flaura2.html) show submenu for “Metastatic EGFRm NSCLC”\n * [NSCLC & Testing](#)\n \n * [Know the driver](/metastatic/flaura2/testing.html#know-the-driver)\n * [Test everyone](/metastatic/flaura2/testing.html#test-everyone)\n * [Confirm before treating](/metastatic/flaura2/testing.html#confirm-before-treatment)\n * [How to test](/metastatic/flaura2/testing.html#how-to-test)\n * [NCCN Guidelines](/metastatic/flaura2/testing.html#nccn-guidelines)\n * [Unmet need](/metastatic/flaura2/testing.html#unmet-need)\n \n * [Efficacy](#)\n \n * [PFS](/metastatic/flaura2/efficacy.html#pfs)\n * [Subgroups](/metastatic/flaura2/efficacy.html#efficacysubgroups)\n * [Additional results](/metastatic/flaura2/efficacy.html#additional-results)\n * [CNS data](/metastatic/flaura2/efficacy.html#cns-data)\n * [FLAURA2 study design](/metastatic/flaura2/efficacy.html#flaura2)\n \n * [Safety](#)\n \n * [FLAURA2 adverse reactions](/metastatic/flaura2/safety-side-effects.html#adverse-reactions)\n * [Laboratory abnormalities](/metastatic/flaura2/safety-side-effects.html#laboratory-abnormalities)\n * [Additional results](/metastatic/flaura2/safety-side-effects.html#additional-results)\n \n * [Dosing](/metastatic/flaura2/dosing.html)\n * [Video](/metastatic/flaura2/video-library.html)\n * [MOA](/metastatic/flaura2/moa.html)\n * [Support](#)\n \n * [Financial support](/metastatic/flaura2/support.html#financial-resources)\n * [HCP resources](/metastatic/flaura2/support.html#hcp-resources)\n \n\n* [About](/about.html)\n* [MOA](/moa.html)\n* [Support](#)\n \n * [Financial support](/support.html#financial)\n * [HCP Resources](/support.html#resources)\n \n* [For APPs & Nurse Teams](#)\n \n * [Dosing](/nurses-and-apps.html#nurse-dosing)\n * [Dose modifications](/nurses-and-apps.html#nurse-dosing-modifications)\n * [Patient monitoring](/nurses-and-apps.html#nurse-patient-monitoring)\n * [Drug interactions](/nurses-and-apps.html#nurse-drug-interactions)\n * [Resources](/nurses-and-apps.html#nurse-resources)\n \n\n* [For Patients](https://www.tagrisso.com)\n* [AZ Medical Information Support](https://medicalinformation.astrazeneca-us.com/)\n* [Contact a Representative](/contact-a-representative.html)\n\nundefined\n\n[\n\nNEW DFS DATA \nAVAILABLE\n\n](/resectable-egfrm-nsclc/efficacy.html)\n\n![10-Years Logo](/content/dam/open-digital/tagrisso-hcp/us/en/desktop/10%20Year%20Badge.Desktop.2X%202.png)\n\nTreat the driver of disease with TAGRISSO\n=========================================\n\n[![Resectable EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/ResectableLung.2X.png)ADAURA RESECTABLE STAGE IB-IIIA EGFRm NSCLCTAGRISSO monotherapy](/resectable/adaura.html)\n\n[![Metastatic EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/Metastatic-lung.svg)FLAURA METASTATIC STAGE IV EGFRm NSCLC TAGRISSO monotherapy](/metastatic/flaura.html)\n\n![New](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/new-badge.png)\n\n[![Unresectable EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/Unresectable_Lung.2X.png)LAURA LOCALLY ADVANCED UNRESECTABLE STAGE III EGFRm NSCLC FOLLOWING CRTTAGRISSO monotherapy](/unresectable/laura.html)\n\n[![Metastatic EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/Metastatic-lung.svg)FLAURA2 LOCALLY ADVANCED OR METASTATIC EGFRm NSCLC TAGRISSO + CT (pem/plat)](/metastatic/flaura2.html)\n\n**\\>66,000 patients treated** \nin the US and counting1\\*\n\n\n-------------------------------------------------------------\n\n**\\>66,000 patients treated** in the US and counting1\\*\n\n\n-----------------------------------------------------------\n\n![Announcing A new indication](/content/dam/open-digital/tagrisso-hcp/us/en/mobile/Announcing_Graphic_Desktop_m.png)\n\n![New](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/new-badge.png)\n\n[![Unresectable EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/Unresectable_Lung.2X.png)LAURA LOCALLY ADVANCED UNRESECTABLE STAGE III EGFRm NSCLC FOLLOWING CRTTAGRISSO monotherapy](/unresectable/laura.html)\n\n[![Resectable EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/ResectableLung.2X.png)ADAURA RESECTABLE STAGE IB-IIIA EGFRm NSCLCTAGRISSO monotherapy](/resectable/adaura.html)\n\n[![Metastatic EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/Metastatic-lung.svg)FLAURA2 LOCALLY ADVANCED OR METASTATIC EGFRm NSCLC TAGRISSO + CT (pem/plat)](/metastatic/flaura2.html)\n\n[![Metastatic EGFRm NSCLC lung](/content/dam/open-digital/tagrisso-hcp/us/en/chemotherapy/Metastatic-lung.svg)FLAURA METASTATIC STAGE IV EGFRm NSCLC TAGRISSO monotherapy](/metastatic/flaura.html)\n\n\\*66,210 patients (resectable EGFRm NSCLC, 1L EGFRm mNSCLC, 1L in combination with chemotherapy \\[pemetrexed + platinum-based\\] for locally advanced or metastatic EGFRm NSCLC, and 2L EGFR T790M mutation-positive mNSCLC) treated from approval in 2015 through April 2024. Based on Brand I&A Team LTP.1\n\nCT (pem/plat), pemetrexed plus platinum-based chemotherapy.\n\n \n\n#### **You are now about to leave the TAGRISSO website**\n\nX\n\nThis link will take you to a site maintained by a third party who is solely responsible for its content.\n\nAstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.\n\nback Continue\n\nThis link will take you to a site maintained by a third party who is solely responsible for its content.\n\nAstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.\n\nCancel Ok\n\nRead More Read Less\n\nIMPORTANT SAFETY INFORMATION\n----------------------------\n\n* There are no contraindications for TAGRISSO\n* TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy; 0.4% of cases were fatal\n\n**ILD/Pneumonitis with TAGRISSO in combination with Pemetrexed and Platinum-based Chemotherapy:**\n\n* * In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal\n\n**ILD/Pneumonitis Following Definitive Platinum-based Chemoradiation Therapy (CRT):**\n\n* * In the LAURA study, following definitive platinum-based CRT, ILD/pneumonitis including radiation pneumonitis, occurred in 80 of the 143 patients (56%) who received TAGRISSO monotherapy and 28 of the 73 patients (38%) who received placebo. There was one fatal case (0.7%), 3.5% Grade 3, 34% Grade 2, and 18% Grade 1 adverse reactions of ILD/pneumonitis in TAGRISSO-treated patients. For TAGRISSO-treated patients, ILD/pneumonitis led to permanent discontinuation of TAGRISSO in 7% of patients and dosage interruptions of TAGRISSO in 35% of patients. Among the 46 patients who were rechallenged with TAGRISSO, 11% had recurrence of ILD/pneumonitis. In the 80 TAGRISSO-treated patients, ILD/pneumonitis resolved in 40%, resolved with sequelae in 1.3%, were resolving in 16%, did not resolve in 41%, and resulted in death in 1.3%\n\nFor patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed. For patients who have received recent definitive platinum-based CRT with Grade 1 ILD/pneumonitis, continue TAGRISSO or interrupt and restart, as appropriate. Permanently discontinue TAGRISSO in patients diagnosed with Grade ≥2 ILD/pneumonitis\n\n* TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Clinical trials of TAGRISSO did not enroll patients with baseline QTc of >470 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia\n* TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the LAURA study, following platinum-based CRT, 3% (4/135) of TAGRISSO-treated patients and no placebo-treated patients experienced LVEF decreases ≥10% and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO\n* Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist\n* Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed\n* Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity\n* Aplastic anemia has been reported in TAGRISSO-treated patients in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated\n* Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose\n* Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose\n* Most common (≥20%) adverse reactions, including laboratory abnormalities, were:\n * TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue\n * TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19\n * TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine\n\nINDICATIONS\n-----------\n\n* TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy\n\n**Please see complete [**Prescribing Information**](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1), including Patient Information for TAGRISSO.**\n\n_You may [**report side effects related to AstraZeneca products**](https://us-aereporting.astrazeneca.com/adverse-events.html). [![link Icon](/content/dam/open-digital/tagrisso-hcp/us/en/global/link-icon.png)](https://us-aereporting.astrazeneca.com/adverse-events.html)_ \n\n1L, first-line; 2L, second-line; AUC, area under the curve; CI, confidence interval; CRT, chemoradiation therapy; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; PS, performance status; q3w, once every 3 weeks; qd, once daily; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. AstraZeneca Media Centre. AURA press release.[ \nhttps://www.astrazeneca.com/media-centre/press-releases/2015/TAGRISSO-AZD9291-approved-by-the-US-FDA-for-patients-with-EGFR-T790M-mutation-positive-metastatic-non-small-cell-lung-cancer-13112015.html.](https://www.astrazeneca.com/media-centre/press-releases/2015/TAGRISSO-AZD9291-approved-by-the-US-FDA-for-patients-with-EGFR-T790M-mutation-positive-metastatic-non-small-cell-lung-cancer-13112015.html) Published November 13, 2015. Accessed September 10, 2020. 3. FDA website. FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations. [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-first-line-treatment-metastatic-nsclc-most-common-egfr-mutations.](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-first-line-treatment-metastatic-nsclc-most-common-egfr-mutations) Published April 19, 2018. Accessed October 13, 2020. 4. FDA website. FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations. [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations.](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations) Published December 18, 2020. Accessed August 11, 2021. 5. Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer \\[press release\\]. AstraZeneca Media Centre; February 16, 2024. 6. AstraZeneca Media Centre. LAURA press release. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-us-approval-in-unresectable-lung-cancer.html. Published September 26, 2024. Accessed September 26, 2024. 7. Data on File. US-89546. AstraZeneca Pharmaceuticals LP. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.11.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 15, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 9. AstraZeneca Media Centre. AURA3 press release. [https://www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-osimertinib-receives-us-fda-full-approval-31032017.html.](https://www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-osimertinib-receives-us-fda-full-approval-31032017.html) Published March 31, 2017. Accessed September 10, 2020.\n\nAEs, adverse events; AUC, area under the curve; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; MRI, magnetic resonance imaging; NSCLC, non-small cell lung cancer; PET, positron emission tomography; PK, pharmacokinetics; T790M, exon 20 threonine 790 methionine substitution; WT, wild-type. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125. 3. Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. _Cancer Discov_. 2014;4(9):1046-1061. 4. Finlay MR, Anderton M, Ashton S, et al. Discovery of a potent and selective EGFR inhibitor (AZD9291) of both sensitizing and T790M resistance mutations that spares the wild type form of the receptor. _J Med Chem_. 2014;57(20):8249-8267. 5. Ballard P, Yates JW, Yang Z, et al. Preclinical comparison of osimertinib with other EGFR-TKls in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. _Clin Cancer Res_. 2016;22(20):5130-5140. 6. Colclough N, Chen K, Johnström P, Fridén M, McGinnity DF. Building on the success of osimertinib: achieving CNS exposure in oncology drug discovery. _Drug Discov Today_. 2019;24(5):1067-1073. 7. Varrone A, Varnäs K, Jucaite A, et al. A PET study in healthy subjects of brain exposure of 11C-labeled osimertinib—a drug intended for treatment of brain metastases in non-small cell lung cancer. _J Cereb Blood Flow Metab_. 2020;40(4):799-807.\n\nReference: 1. Data on File. US-74462. AstraZeneca Pharmaceuticals LP.\n\nCI, confidence interval; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; TKI, tyrosine kinase inhibitor.\n\nReferences: 1. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 3. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.\n\nAJCC, American Joint Committee on Cancer; CNS, central nervous system; ctDNA, circulating tumor DNA; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; OR, odds ratio; PD-L1, programmed death-ligand 1; RT, radiotherapy. References: 1. MacLean M, Luo X, Wang S, Kernstine K, Gerber DE, Xie Y. Outcomes of neoadjuvant and adjuvant chemotherapy in stage 2 and 3 non-small cell lung cancer: an analysis of the National Cancer Database. _Oncotarget_. 2018;9(36):24470-24479. 2. Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in patterns of recurrence in early-stage versus locally advanced non-small cell lung cancer. _Ann Thorac Surg_. 2014;98(5):1755-1760. 3. Galvez C, Jacob S, Finkelman BS, et al. The role of EGFR mutations in predicting recurrence in early and locally advanced lung adenocarcinoma following definitive therapy. _Oncotarget_. 2020;11(21):1953-1960. 4. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 5. Dong ZY, Zhang JT, Liu SY, et al. EGFR mutation correlates with uninflamed phenotype and weak immunogenicity, causing impaired response to PD-1 blockade in non-small cell lung cancer. _Oncoimmunology_. 2017;6(11):e1356145. 6. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777 \\[supplementary appendix\\]. 7. D’Angelo SP, Janjigian YY, Ahye N, et al. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. _J Thorac Oncol_. 2012;7(12):1815-1822. 8. Cho JH, Zhou W, Choi YL, et al. Retrospective molecular epidemiology study of PD-L1 expression in patients with EGFR-mutant non-small cell lung cancer. _Cancer Res Treat_. 2018;50(1):95-102. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 10. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777. 11. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. _JAMA_. 2014;311(19):1998-2006. 12. Cheema PK, Menjak IB, Winterton-Perks Z, et al. Impact of reflex EGFR/ALK testing on time to treatment of patients with advanced nonsquamous non-small-cell lung cancer. _J Oncol Pract_. 2017;13(2):e130-e138. 13. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442. 14. Freeman RK, Ascioti AJ, Dake M, Mahidhara RS. The effects of a multidisciplinary care conference on the quality and cost of care for lung cancer patients. _Ann Thorac Surg_. 2015;100(5):1834-1838.\n\nAJCC, American Joint Committee on Cancer; CI, confidence interval; CNS, central nervous system; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ex19del, exon 19 deletion; FDA, US Food and Drug Administration; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; po, by mouth; PS, performance status; qd, once daily; QoL, quality of life; TKI, tyrosine kinase inhibitor; WHO, World Health Organization. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186. 3. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147. 4. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186 \\[protocol\\]. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 6. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147 \\[supplementary appendix\\]. 7. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[protocol\\]. 8. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643. 9. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643 \\[supplementary table\\]. 10. Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A III, eds. _AJCC Cancer Staging Manual_. 7th ed. New York, NY: Springer; 2010. 11. Rami-Porta R, Asamura H, Travis WD, Rusch VW. Lung cancer—major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. _CA Cancer J Clin_. 2017;67(2):138-155. 12. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723. 13. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[supplementary appendix\\]. 14. MacLean M, Luo X, Wang S, Kernstine K, Gerber DE, Xie Y. Outcomes of neoadjuvant and adjuvant chemotherapy in stage 2 and 3 non-small cell lung cancer: an analysis of the National Cancer Database. _Oncotarget_. 2018;9(36):24470-24479.\n\nARs, adverse reactions; CTCAE, Common Terminology Criteria for Adverse Events; NCI, National Cancer Institute; OS, overall survival; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723. 3. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147.\n\nAJCC, American Joint Committee on Cancer; ARs, adverse reactions; CI, confidence interval; CNS, central nervous system; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ex19del, exon 19 deletion; FDA, US Food and Drug Administration; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NE, not estimable; NSCLC, non-small cell lung cancer; OR, odds ratio; OS, overall survival; po, by mouth; qd, once daily; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia; RT, radiotherapy; TKI, tyrosine kinase inhibitor. References: 1. Uramoto H, Tanaka F. Recurrence after surgery in patients with NSCLC. _Transl Lung Cancer Res_. 2014;3(4):242-249. 2. Chouaid C, Danson S, Andreas S, et al. Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study. _Lung Cancer_. 2018;124:310-316. 3. MacLean M, Luo X, Wang S, Kernstine K, Gerber DE, Xie Y. Outcomes of neoadjuvant and adjuvant chemotherapy in stage 2 and 3 non-small cell lung cancer: an analysis of the National Cancer Database. _Oncotarget_. 2018;9(36):24470-24479. 4. Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in patterns of recurrence in early-stage versus locally advanced non-small cell lung cancer. _Ann Thorac Surg_. 2014;98(5):1755-1760. 5. Dong ZY, Zhang JT, Liu SY, et al. EGFR mutation correlates with uninflamed phenotype and weak immunogenicity, causing impaired response to PD-1 blockade in non-small cell lung cancer. _Oncoimmunology_. 2017;6(11):e1356145. 6. Galvez C, Jacob S, Finkelman BS, et al. The role of EGFR mutations in predicting recurrence in early and locally advanced lung adenocarcinoma following definitive therapy. _Oncotarget_. 2020;11(21):1953-1960. 7. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777 \\[supplementary appendix\\]. 8. D'Angelo SP, Janjigian YY, Ahye N, et al. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. _J Thorac Oncol_. 2012;7(12):1815-1822. 9. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 10. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777. 11. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. _JAMA_. 2014;311(19):1998-2006. 12. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 13. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186. 14. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147. 15. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186 \\[protocol\\]. 16. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 17. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147 \\[supplementary appendix\\]. 18. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[protocol\\]. 19. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643. 20. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643 \\[supplementary table\\]. 21. Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A III, eds. _AJCC Cancer Staging Manual_. 7th ed. New York, NY: Springer; 2010. 22. Rami-Porta R, Asamura H, Travis WD, Rusch VW. Lung cancer—major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. _CA Cancer J Clin_. 2017;67(2):138-155. 23. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723. 24. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[supplementary appendix\\]. 25. Freeman RK, Ascioti AJ, Dake M, Mahidhara RS. The effects of a multidisciplinary care conference on the quality and cost of care for lung cancer patients. _Ann Thorac Surg_. 2015;100(5):1834-1838. 26. Bilfinger TV, Albano D, Perwaiz M, Keresztes R, Nemesure B. Survival outcomes among lung cancer patients treated using a multidisciplinary team approach. _Clin Lung Cancer_. 2018;19(4):346-351. 27. Wang J, Kuo YF, Freeman J, Goodwin JS. Increasing access to medical oncology consultation in older patients with stage II-IIIA non-small-cell lung cancer. _Med Oncol_. 2008;25(2):125-132. 28. Postmus PE, Kerr KM, Oudkerk M, et al; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. _Ann Oncol_. 2017;28(suppl4):iv1-iv21. 29. Zuccato JA, Ellis PM. Improving referral of patients for consideration of adjuvant chemotherapy after surgical resection of lung cancer. _Curr Oncol_. 2012;19(6):e422-e427. 30. Hirsch FR, Kerr KM, Bunn PA Jr, et al. Molecular and immune biomarker testing in squamous-cell lung cancer: effect of current and future therapies and technologies. _Clin Lung Cancer._ 2018;19(4):331-339.\n\n1L, first-line; 2L, second-line; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NG, nasogastric; NSCLC, non-small cell lung cancer; T790M, exon 20 threonine 790 methionine substitution. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-55578. AstraZeneca Pharmaceuticals LP. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nCI, confidence interval; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.\n\n1L, first-line; AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; EHR, electronic health records; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; G12C, glycine-to-cysteine substitution at codon 12; HER2, human epidermal growth factor receptor; ICI, immune checkpoint inhibitor; ILD, interstitial lung disease; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; ORR, overall response rate; PD-L1, programmed death-ligand 1; QNS, quantity not sufficient; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. References: 1. Jordan EJ, Kim HR, Arcila ME, et al. Prospective comprehensive molecular characterization of lung adenocarcinomas for efficient patient matching to approved and emerging therapies. _Cancer Discov_. 2017;7(6):596-609. 2. Gatalica Z, Xiu J, Swensen J, Vranic S. Molecular characterization of cancers with NTRK gene fusions. _Mod Pathol_. 2019;32(1):147-153. 3. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to [NCCN.org](https://www.nccn.org/). NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Robert NJ, Espirito JL, Chen L, et al. Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. _Lung Cancer_. 2022;166:197-204. 6. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187 \\[supplementary appendix 2\\]. 7. Data on File. US-42770. EGFR TKI prescription data from Flatiron Health EHR-derived database (included patients who started treatment between October 2017 to April 2020, all data collected online). Ipsos data © Ipsos 2020, all rights reserved. AstraZeneca Pharmaceuticals LP. 8. Oshima Y, Tanimoto T, Yuji K, Tojo A. EGFR-TKI-associated interstitial pneumonitis in nivolumab-treated patients with non-small cell lung cancer. _JAMA Oncol_. 2018;4(8):1112-1115. 9. Schoenfeld AJ, Arbour KC, Rizvi H, et al. Severe immune-related adverse events are common with sequential PD-(L)1 blockade and osimertinib. _Ann Oncol_. 2019;30(5):839-844. 10. Ohe Y, Kato T, Sakai F, et al. Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan. _Jpn J Clin Oncol_. 2020;50(8):909-919. 11. Yamaguchi O, Kaira K, Kawasaki T, et al. Severe hepatotoxicity due to osimertinib after nivolumab therapy in patients with non-small cell lung cancer harboring EGFR mutation. _Thorac Cancer_. 2020;11(4):1045-1051. 12. Uchida T, Kaira K, Yamaguchi O, et al. Different incidence of interstitial lung disease according to different kinds of EGFR-tyrosine kinase inhibitors administered immediately before and/or after anti-PD-1 antibodies in lung cancer. _Thorac Cancer_. 2019;10(4):975-979. 13. Kotake M, Murakami H, Naito T, et al. Practical use of osimertinib in Japanese patients with EGFR T790M mutation positive advanced non-small-cell lung cancer \\[abstract\\]. _Ann Oncol_. 2016;27(suppl9):ix147. 14. Keytruda \\[package insert\\]. Whitehouse Station, NJ: Merck & Co., Inc; 2023. 15. Tecentriq \\[package insert\\]. South San Francisco, CA: Genentech Inc.; 2023. 16. Opdivo \\[package insert\\]. Princeton, NJ: Bristol-Myers Squibb Company; 2023. 17. Yervoy \\[package insert\\]. Princeton, NJ: Bristol-Myers Squibb Company; 2023. 18. Libtayo \\[package insert\\]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2023. 19. Lisberg A, Cummings A, Goldman JW, et al. A phase II study of pembrolizumab in EGFR-mutant, PD-L1+, tyrosine kinase inhibitor naïve patients with advanced NSCLC. _J Thorac Oncol_. 2018;13(8):1138-1145. 20. Reck M, Rodríguez-Abreu D, Robinson AG, et al; KEYNOTE-024 Investigators. Pembrolizumab versus chemotherapy for PD-L1–positive non-small-cell lung cancer. _N Engl J Med_. 2016;375(19):1823-1833. 21. Mok TSK, Wu YL, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. _Lancet_. 2019;393(10183):1819-1830. 22. Langer CJ, Gadgeel SM, Borghaei H, et al; KEYNOTE-021 Investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. _Lancet Oncol_. 2016;17(11):1497-1508. 23. Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al; KEYNOTE-189 Investigators. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer. _N Engl J Med_. 2018;378(22):2078-2092. 24. Carbone DP, Reck M, Paz-Ares L, et al; CheckMate 026 Investigators. First-line nivolumab in stage IV or recurrent non-small-cell-lung cancer. _N Engl J Med_. 2017;376(25):2415-2426. 25. Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. _N Engl J Med_. 2018;378(22):2093-2104. 26. Paz-Ares L, Ciuleanu TE, Cobo M, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate LA): an international, randomised, open-label, phase 3 trial \\[published correction appears in _Lancet Oncol_. 2021;22(3):e92\\]. _Lancet Oncol_. 2021;22(2):198-211. 27. West H, McCleod M, Hussein M, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. _Lancet Oncol_. 2019;20(7):924-937. 28. Socinski MA, Jotte RM, Cappuzzo F, et al; IMpower150 Study Group. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. _N Engl J Med_. 2018;378(24):2288-2301. 29. Nishio M, Barlesi F, West H, et al. Atezolizumab plus chemotherapy for first-line treatment of nonsquamous NSCLC: results from the randomized phase 3 IMpower132 trial. _J Thorac Oncol_. 2021;16(4):653-664. 30. Herbst RS, Giaccone G, de Marinis F, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. _N Engl J Med_. 2020;383(14):1328-1339. 31. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PDL1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. _Lancet_. 2021;397(10274):592-604. 32. Gogishvili M, Melkadze T, Makharadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. _Nat Med_. 2022;28(11):2374-2380. 33. Johnson ML, Cho BC, Luft A, et al. Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non-small-cell lung cancer: the phase III POSEIDON study. _J Clin Oncol_. 2023;41(6):1213-1227. 34. Lumakras \\[package insert\\]. Thousand Oaks, CA: Amgen Inc.; 2023. 35. Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. _N Engl J Med_. 2021;384(25):2371-2381. 36. Rybrevant \\[package insert\\]. Horsham, PA: Janssen Biotech, Inc.; 2022. 37. ENHERTU \\[package insert\\]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2022. 38. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328. 39. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328 \\[supplemental table\\]. 40. D’Incecco A, Andreozzi M, Ludovini V, et al. PD-1 and PD-L1 expression in molecularly selected non-small-cell lung cancer patients. _Br J Cancer_. 2015;112(1):95-102. 41. Dietel M, Savelov N, Salanova R, et al. Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer: the global, multicenter EXPRESS study. _Lung Cancer_. 2019;134:174-179. 42. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. _J Thorac Oncol_. 2020;15(1):138-143. 43. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. _Clin Cancer Res_. 2019;25(15):4691-4700. 44. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. _JAMA Oncol_. 2019;5(2):173-180. 45. Merker JD, Oxnard GR, Compton C, et al. Circulating tumor DNA analysis in patients with cancer: American Society of Clinical Oncology and College of American Pathologists joint review. _J Clin Oncol_. 2018;36(16):1631-1641.\n\nAEs, adverse events; AUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CR, complete response; ctDNA, circulating tumor DNA; DoR, duration of response; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; MRI, magnetic resonance imaging; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; OR, odds ratio; ORR, overall response rate; OS, overall survival; PET, positron emission tomography; PFS, progression-free survival; PK, pharmacokinetics; po, by mouth; PR, partial response; PS, performance status; qd, once daily; RECIST, Response Evaluation Criteria in Solid Tumors; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor; WHO, World Health Organization. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Ramalingam SS, Vansteenkiste J, Planchard D, et al; FLAURA Investigators. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. _N Engl J Med_. 2020;382(1):41-50. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125. 5. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125 \\[protocol\\]. 6. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 7. Rangachari D, Yamaguchi N, VanderLaan PA, et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. _Lung Cancer_. 2015;88(1):108-111. 8. Reungwetwattana T, Nakagawa K, Cho BC, et al. CNS response to osimertinib versus standard epidermal growth factor receptor tyrosine kinase inhibitors in patients with untreated EGFR-mutated advanced non-small-cell lung cancer. _J Clin Oncol_. 2018;36(33):3290-3297. 9. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125 \\[supplementary appendix\\]. 10. Ballard P, Yates JW, Yang Z, et al. Preclinical comparison of osimertinib with other EGFR-TKIs in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. _Clin Cancer Res_. 2016;22(20):5130-5140. 11. Colclough N, Chen K, Johnström P, Fridén M, McGinnity DF. Building on the success of osimertinib: achieving CNS exposure in oncology drug discovery. _Drug Discov Today_. 2019;24(5):1067-1073. 12. Varrone A, Varnäs K, Jucaite A, et al. A PET study in healthy subjects of brain exposure of 11C-labeled osimertinib—a drug intended for treatment of brain metastases in non-small cell lung cancer. \n_J Cereb Blood Flow Metab_. 2020;40(4):799-807.\n\nALT, alanine aminotransferase; ARs, adverse reactions; AST, aspartate transaminase; CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; ILD, interstitial lung disease; NCI, National Cancer Institute; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia; RTI, respiratory tract infection; TKI, tyrosine kinase inhibitor. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med._ 2018;378(2):113-125.\n\nAUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CTCAE, Common Terminology Criteria for Adverse Events; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; HR, hazard ratio; NA, not applicable; NCI, National Cancer Institute; NSCLC, non-small cell lung cancer; ORR, overall response rate; PFS, progression-free survival; po, by mouth; PS, performance status; qd, once daily; QTc, heart-rate corrected QT interval; QTcF, corrected QT interval by Fridericia; RECIST, Response Evaluation Criteria in Solid Tumors; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor; WHO, World Health Organization. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Mok TS, Wu YL, Ahn MJ, et al; AURA3 Investigators. Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. _N Engl J Med_. 2017;376(7):629-640. 3. cobas® EGFR Mutation Test v2 \\[package insert\\]. Indianapolis, IN: Roche Molecular Systems, Inc.; 2021. 4. Guardant360 CDx \\[package insert\\]. Redwood City, CA: Guardant Health, Inc.; 2023.\n\nEGFR, epidermal growth factor receptor; IO, immunotherapy; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; TKI, tyrosine kinase inhibitor.\n\n1L, first-line; 2L, second-line; APPs, Advanced Practice Providers; AUC, area under the curve; BCRP, breast cancer resistance protein; CRT, chemoradiation therapy; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; CYP, cytochrome P450; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; LVEF, left ventricular ejection fraction; mNSCLC, metastatic non-small cell lung cancer; NG, nasogastric; NSCLC, non-small cell lung cancer; P-GP, P-glycoprotein; q3w, once every 3 weeks; qd, once daily; QTc, heart rate-corrected QT interval; T790M, exon 20 threonine 790 methionine substitution.References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nAR, adverse reaction; AUC, area under the curve; CTCAE, Common Terminology Criteria for Adverse Events; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFRm, epidermal growth factor receptor mutation; NCI, National Cancer Institute; NSCLC, non-small cell lung cancer; po, by mouth; q3w, once every 3 weeks; qd, once daily; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia.References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Planchard D, Jänne PA, Cheng Y, et al. FLAURA2: safety and CNS outcomes of first-line osimertinib ± chemotherapy in EGFRm advanced NSCLC \\[oral presentation\\]. 2023 ESMO Congress; October 20-24, 2023; Madrid, Spain. 3. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[supplementary appendix\\]. 4. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948. 5. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\].\n\n1L, first-line; 2L, second-line; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; LVEF, left ventricular ejection fraction; mNSCLC, metastatic non-small cell lung cancer; NG, nasogastric; NSCLC, non-small cell lung cancer; po, by mouth; q3w, once every 3 weeks; qd, once daily; T790M, exon 20 threonine 790 methionine substitution. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-55578. AstraZeneca Pharmaceuticals LP. 3. Data on File. US-74462. AstraZeneca Pharmaceuticals LP.\n\nAUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CR, complete response; ctDNA, circulating tumor DNA; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; DoR, duration of response; ECG, electrocardiogram; eCRF, electronic case-report form; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; Ex19del, exon 19 deletion; HR, hazard ratio; ILD, interstitial lung disease; L858R, exon 21 leucine 858 arginine substitution; mOS, median overall survival; mPFS, median progression-free survival; MRI, magnetic resonance imaging; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; PR, partial response; PS, performance status; q3w, once every 3 weeks; qd, once daily; RECIST, Response Evaluation Criteria in Solid Tumors; TKI, tyrosine kinase inhibitor; WHO, World Health Organization.References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948. 3. Valdiviezo N, Okamoto I, Hughes BGM, et al. First-line osimertinib ± platinum-pemetrexed in EGFRm advanced NSCLC: FLAURA2 post-progression outcomes \\[oral presentation\\]. Presented at: 2024 European Lung Cancer Congress; March 20-23, 2024; Prague, Czech Republic. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Jänne PA, Planchard D, Cheng Y, et al. Osimertinib with/without platinum-based chemotherapy as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA2) \\[oral presentation\\]. Presented at: 2023 World Conference on Lung Cancer; September 9-12, 2023; Singapore. 6. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[supplementary appendix\\]. 7. Jänne PA, Planchard D, Kobayashi K, et al. CNS efficacy of osimertinib with or without chemotherapy in epidermal growth factor receptor-mutated advanced non-small-cell lung cancer. _J Clin Oncol_. 2024;42(7):808-820. 8. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\].\n\n1L, first-line; 2L, second-line; CRT, chemoradiotherapy; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; T790M, exon 20 threonine 790 methionine substitution. Reference: 1. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nAUC, area under the curve; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily. Reference: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.\n\n1L, first-line; AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CI, confidence interval; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; EHR, electronic health records; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; Ex19del, exon 19 deletion; G12C, glycine-to-cysteine substitution at codon 12; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; ICI, immune checkpoint inhibitor; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; PD-L1, programmed death-ligand 1; PFS, progression-free survival; QNS, quantity not sufficient; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; SCLC, small cell lung cancer; SEER, Surveillance, Epidemiology, and End Results; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. References: 1. Jordan EJ, Kim HR, Arcila ME, et al. Prospective comprehensive molecular characterization of lung adenocarcinomas for efficient patient matching to approved and emerging therapies. _Cancer Discov_. 2017;7(6):596-609. 2. Gatalica Z, Xiu J, Swensen J, Vranic S. Molecular characterization of cancers with NTRK gene fusions. _Mod Pathol_. 2019;32(1):147-153. 3. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 12, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Robert NJ, Espirito JL, Chen L, et al. Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. _Lung Cancer_. 2022;166:197-204. 6. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187 \\[supplementary appendix 2\\]. 7. Data on File. US-76421. AstraZeneca Pharmaceuticals LP. 8. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328. 9. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328 \\[supplemental table\\]. 10. Dietel M, Savelov N, Salanova R, et al. Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer: the global, multicenter EXPRESS study. _Lung Cancer_. 2019;134:174-179. 11. D’Incecco A, Andreozzi M, Ludovini V, et al. PD-1 and PD-L1 expression in molecularly selected non-small-cell lung cancer patients. _Br J Cancer_. 2015;112(1):95-102. 12. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. _J Thorac Oncol_. 2020;15(1):138-143. 13. Lumakras \\[package insert\\]. Thousand Oaks, CA: Amgen Inc.; 2023. 14. Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. _N Engl J Med_. 2021;384(25):2371-2381. 15. ENHERTU \\[package insert\\]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2022. 16. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. _Clin Cancer Res_. 2019;25(15):4691-4700. 17. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. _JAMA Oncol_. 2019;5(2):173-180. 18. Merker JD, Oxnard GR, Compton C, et al. Circulating tumor DNA analysis in patients with cancer: American Society of Clinical Oncology and College of American Pathologists joint review. _J Clin Oncol_. 2018;36(16):1631-1641. 19. Peters S, Bexelius C, Munk V, Leighl N. The impact of brain metastasis on quality of life, resource utilization and survival in patients with non-small-cell lung cancer. _Cancer Treat Rev_. 2016;45:139-162. 20. Su PL, Wu YL, Chang WY, et al. Preventing and treating brain metastases with three first-line EGFR-tyrosine kinase inhibitors in patients with EGFR mutation-positive advanced non-small cell lung cancer. _Ther Adv Med Oncol_. 2018;10:1758835918797589. 21. Koyama N, Watanabe Y, Iwai Y, et al. Distinct benefit of overall survival between patients with non-small-cell lung cancer harboring EGFR exon 19 deletion and exon 21 L858R substitution. _Chemotherapy_. 2017;62(3):151-158. 22. Sheng M, Wang F, Zhao Y, et al. Comparison of clinical outcomes of patients with non-small-cell lung cancer harbouring epidermal growth factor receptor exon 19 or exon 21 mutations after tyrosine kinase inhibitors treatment: a meta-analysis. _Eur J Clin Pharmacol_. 2016;72(1):1-11. 23. Li J, Zhu H, Sun L, Xu W, Wang X. Prognostic value of site-specific metastases in lung cancer: a population based study. _J Cancer_. 2019;10(14):3079-3086. 24. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 25. Rangachari D, Yamaguchi N, VanderLaan PA, et al. Brain metastases in patients with EGFR-mutated or ALK rearranged non-small-cell lung cancers. _Lung Cancer_. 2015;88(1):108-111.\n\n1L, first-line; 2L, second-line; AUC, area under the curve; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; CRT, chemoradiotherapy; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; mNSCLC, metastatic non-small cell lung cancer; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. Reference: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.\n\nALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; cCRT, concurrent chemoradiotherapy; CNS, central nervous system; CRT, chemoradiotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; FDA, US Food and Drug Administration; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; TKI, tyrosine kinase inhibitor.References: 1. Park SE, Noh JM, Kim YJ, et al. EGFR mutation is associated with short progression-free survival in patients with stage III non-squamous cell lung cancer treated with concurrent chemoradiotherapy. _Cancer Res Treat_. 2019;51(2):493-501. 2. Kim H, Park S, Jung HA, et al. EGFR mutation–positive unresectable stage III non-squamous lung cancer is associated with a high incidence of brain metastasis. _Cancer Res Treat_. 2023;55(2):498-505. 3. Tanaka K, Hida T, Oya Y, et al. EGFR mutation impact on definitive concurrent chemoradiation therapy for inoperable stage III adenocarcinoma. _J Thorac Oncol_. 2015;10(12):1720-1725. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 6. Aggarwal C, Bubendorf L, Cooper WA, et al. Molecular testing in stage I-III non-small cell lung cancer: approaches and challenges. _Lung Cancer_. 2021;162:42-53. 7. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442. 8. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\].\n\nAJCC/UICC, American Joint Committee on Cancer/Union for International Cancer Control; ALK, anaplastic lymphoma kinase; BICR, blinded independent central review; BRAF, v-raf murine sarcoma viral oncogene homolog B1; cCRT, concurrent chemoradiotherapy; CI, confidence interval; CNS, central nervous system; CR, complete response; CRT, chemoradiotherapy; CT, computed tomography; DoR, duration of response; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; Ex19del, exon 19 deletion; HR, hazard ratio; ILD, interstitial lung disease; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mPFS, median progression-free survival; MRI, magnetic resonance imaging; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; sCRT, sequential chemoradiotherapy; SD, stable disease; TKI, tyrosine kinase inhibitor; WHO PS, World Health Organization performance status. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597. 3. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597 \\[supplementary appendix\\]. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597 \\[protocol\\]. 6. Aggarwal C, Bubendorf L, Cooper WA, et al. Molecular testing in stage I-III non-small cell lung cancer: approaches and challenges. _Lung Cancer_. 2021;162:42-53. 7. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442.\n\nARs, adverse reactions; CPK, creatine phosphokinase; CTCAE, Common Terminology Criteria for Adverse Events; ILD, interstitial lung disease; NCI, National Cancer Institute; QTc, heart rate-corrected QT interval. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597.\n\nALK, anaplastic lymphoma kinase; BICR, blinded independent central review; BRAF, v-raf murine sarcoma viral oncogene homolog B1; cCRT, concurrent chemoradiotherapy; CI, confidence interval; CNS, central nervous system; CR, complete response; CRT, chemoradiotherapy; CTCAE, Common Terminology Criteria for Adverse Events; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; Ex19del, exon 19 deletion; FDA, US Food and Drug Administration; HR, hazard ratio; ILD, interstitial lung disease; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mPFS, median progression-free survival; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NCI, National Cancer Institute; NE, not estimable; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; QTc, heart rate-corrected QT interval; RECIST, Response Evaluation Criteria in Solid Tumors; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; SD, stable disease; TKI, tyrosine kinase inhibitor. References: 1. Park SE, Noh JM, Kim YJ, et al. EGFR mutation is associated with short progression-free survival in patients with stage III non-squamous cell lung cancer treated with concurrent chemoradiotherapy. _Cancer Res Treat._ 2019;51(2):493-501. 2. Kim H, Park S, Jung HA, et al. EGFR mutation–positive unresectable stage III non-squamous lung cancer is associated with a high incidence of brain metastasis. _Cancer Res Treat._ 2023;55(2):498-505. 3. Tanaka K, Hida T, Oya Y, et al. EGFR mutation impact on definitive concurrent chemoradiation therapy for inoperable stage III adenocarcinoma. _J Thorac Oncol._ 2015;10(12):1720-1725. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 6. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\]. 7. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med_. 2024;391(7):585-597. 8. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med_. 2024;391(7):585-597 \\[supplementary appendix\\]. 9. Aggarwal C, Bubendorf L, Cooper WA, et al. Molecular testing in stage I-III non-small cell lung cancer: approaches and challenges. _Lung Cancer_. 2021;162:42-53. 10. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442.\n\n1L, first-line; 2L, second-line; CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; NCI, National Cancer Institute; NG, nasogastric; NSCLC, non-small cell lung cancer; QTc, heart rate-corrected QT interval; T790M, exon 20 threonine 790 methionine substitution. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nEGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; NSCLC, non-small cell lung cancer; PET, positron emission tomography; PK, pharmacokinetics; T790M, exon 20 threonine 790 methionine substitution; WT, wild-type. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125. 3. Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. _Cancer Discov_. 2014;4(9):1046-1061. 4. Finlay MR, Anderton M, Ashton S, et al. Discovery of a potent and selective EGFR inhibitor (AZD9291) of both sensitizing and T790M resistance mutations that spares the wild type form of the receptor. _J Med Chem_. 2014;57(20):8249-8267.\n\nIMPORTANT SAFETY INFORMATION\n----------------------------\n\n* There are no contraindications for TAGRISSO\n* TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy; 0.4% of cases were fatal\n\n**ILD/Pneumonitis with TAGRISSO in combination with Pemetrexed and Platinum-based Chemotherapy:**\n\n* * In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal\n\n**ILD/Pneumonitis Following Definitive Platinum-based Chemoradiation Therapy (CRT):**\n\n* * In the LAURA study, following definitive platinum-based CRT, ILD/pneumonitis including radiation pneumonitis, occurred in 80 of the 143 patients (56%) who received TAGRISSO monotherapy and 28 of the 73 patients (38%) who received placebo. There was one fatal case (0.7%), 3.5% Grade 3, 34% Grade 2, and 18% Grade 1 adverse reactions of ILD/pneumonitis in TAGRISSO-treated patients. For TAGRISSO-treated patients, ILD/pneumonitis led to permanent discontinuation of TAGRISSO in 7% of patients and dosage interruptions of TAGRISSO in 35% of patients. Among the 46 patients who were rechallenged with TAGRISSO, 11% had recurrence of ILD/pneumonitis. In the 80 TAGRISSO-treated patients, ILD/pneumonitis resolved in 40%, resolved with sequelae in 1.3%, were resolving in 16%, did not resolve in 41%, and resulted in death in 1.3%\n\nFor patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed. For patients who have received recent definitive platinum-based CRT with Grade 1 ILD/pneumonitis, continue TAGRISSO or interrupt and restart, as appropriate. Permanently discontinue TAGRISSO in patients diagnosed with Grade ≥2 ILD/pneumonitis\n\n* TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Clinical trials of TAGRISSO did not enroll patients with baseline QTc of >470 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia\n* TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the LAURA study, following platinum-based CRT, 3% (4/135) of TAGRISSO-treated patients and no placebo-treated patients experienced LVEF decreases ≥10% and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO\n* Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist\n* Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed\n* Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity\n* Aplastic anemia has been reported in TAGRISSO-treated patients in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated\n* Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose\n* Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose\n* Most common (≥20%) adverse reactions, including laboratory abnormalities, were:\n * TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue\n * TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19\n * TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine\n\nINDICATIONS\n-----------\n\n* TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n* TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy\n\n**Please see complete [**Prescribing Information**](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1), including Patient Information for TAGRISSO.**\n\n_You may [**report side effects related to AstraZeneca products**](https://us-aereporting.astrazeneca.com/adverse-events.html). [![link Icon](/content/dam/open-digital/tagrisso-hcp/us/en/global/link-icon.png)](https://us-aereporting.astrazeneca.com/adverse-events.html)_ \n\n1L, first-line; 2L, second-line; AUC, area under the curve; CI, confidence interval; CRT, chemoradiation therapy; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; PS, performance status; q3w, once every 3 weeks; qd, once daily; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. AstraZeneca Media Centre. AURA press release.[ \nhttps://www.astrazeneca.com/media-centre/press-releases/2015/TAGRISSO-AZD9291-approved-by-the-US-FDA-for-patients-with-EGFR-T790M-mutation-positive-metastatic-non-small-cell-lung-cancer-13112015.html.](https://www.astrazeneca.com/media-centre/press-releases/2015/TAGRISSO-AZD9291-approved-by-the-US-FDA-for-patients-with-EGFR-T790M-mutation-positive-metastatic-non-small-cell-lung-cancer-13112015.html) Published November 13, 2015. Accessed September 10, 2020. 3. FDA website. FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations. [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-first-line-treatment-metastatic-nsclc-most-common-egfr-mutations.](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-first-line-treatment-metastatic-nsclc-most-common-egfr-mutations) Published April 19, 2018. Accessed October 13, 2020. 4. FDA website. FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations. [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations.](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations) Published December 18, 2020. Accessed August 11, 2021. 5. Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer \\[press release\\]. AstraZeneca Media Centre; February 16, 2024. 6. AstraZeneca Media Centre. LAURA press release. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-us-approval-in-unresectable-lung-cancer.html. Published September 26, 2024. Accessed September 26, 2024. 7. Data on File. US-89546. AstraZeneca Pharmaceuticals LP. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.11.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 15, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 9. AstraZeneca Media Centre. AURA3 press release. [https://www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-osimertinib-receives-us-fda-full-approval-31032017.html.](https://www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-osimertinib-receives-us-fda-full-approval-31032017.html) Published March 31, 2017. Accessed September 10, 2020.\n\nAEs, adverse events; AUC, area under the curve; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; MRI, magnetic resonance imaging; NSCLC, non-small cell lung cancer; PET, positron emission tomography; PK, pharmacokinetics; T790M, exon 20 threonine 790 methionine substitution; WT, wild-type. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125. 3. Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. _Cancer Discov_. 2014;4(9):1046-1061. 4. Finlay MR, Anderton M, Ashton S, et al. Discovery of a potent and selective EGFR inhibitor (AZD9291) of both sensitizing and T790M resistance mutations that spares the wild type form of the receptor. _J Med Chem_. 2014;57(20):8249-8267. 5. Ballard P, Yates JW, Yang Z, et al. Preclinical comparison of osimertinib with other EGFR-TKls in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. _Clin Cancer Res_. 2016;22(20):5130-5140. 6. Colclough N, Chen K, Johnström P, Fridén M, McGinnity DF. Building on the success of osimertinib: achieving CNS exposure in oncology drug discovery. _Drug Discov Today_. 2019;24(5):1067-1073. 7. Varrone A, Varnäs K, Jucaite A, et al. A PET study in healthy subjects of brain exposure of 11C-labeled osimertinib—a drug intended for treatment of brain metastases in non-small cell lung cancer. _J Cereb Blood Flow Metab_. 2020;40(4):799-807.\n\nReference: 1. Data on File. US-74462. AstraZeneca Pharmaceuticals LP.\n\nCI, confidence interval; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; TKI, tyrosine kinase inhibitor.\n\nReferences: 1. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 3. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.\n\nAJCC, American Joint Committee on Cancer; CNS, central nervous system; ctDNA, circulating tumor DNA; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; OR, odds ratio; PD-L1, programmed death-ligand 1; RT, radiotherapy. References: 1. MacLean M, Luo X, Wang S, Kernstine K, Gerber DE, Xie Y. Outcomes of neoadjuvant and adjuvant chemotherapy in stage 2 and 3 non-small cell lung cancer: an analysis of the National Cancer Database. _Oncotarget_. 2018;9(36):24470-24479. 2. Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in patterns of recurrence in early-stage versus locally advanced non-small cell lung cancer. _Ann Thorac Surg_. 2014;98(5):1755-1760. 3. Galvez C, Jacob S, Finkelman BS, et al. The role of EGFR mutations in predicting recurrence in early and locally advanced lung adenocarcinoma following definitive therapy. _Oncotarget_. 2020;11(21):1953-1960. 4. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 5. Dong ZY, Zhang JT, Liu SY, et al. EGFR mutation correlates with uninflamed phenotype and weak immunogenicity, causing impaired response to PD-1 blockade in non-small cell lung cancer. _Oncoimmunology_. 2017;6(11):e1356145. 6. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777 \\[supplementary appendix\\]. 7. D’Angelo SP, Janjigian YY, Ahye N, et al. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. _J Thorac Oncol_. 2012;7(12):1815-1822. 8. Cho JH, Zhou W, Choi YL, et al. Retrospective molecular epidemiology study of PD-L1 expression in patients with EGFR-mutant non-small cell lung cancer. _Cancer Res Treat_. 2018;50(1):95-102. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 10. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777. 11. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. _JAMA_. 2014;311(19):1998-2006. 12. Cheema PK, Menjak IB, Winterton-Perks Z, et al. Impact of reflex EGFR/ALK testing on time to treatment of patients with advanced nonsquamous non-small-cell lung cancer. _J Oncol Pract_. 2017;13(2):e130-e138. 13. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442. 14. Freeman RK, Ascioti AJ, Dake M, Mahidhara RS. The effects of a multidisciplinary care conference on the quality and cost of care for lung cancer patients. _Ann Thorac Surg_. 2015;100(5):1834-1838.\n\nAJCC, American Joint Committee on Cancer; CI, confidence interval; CNS, central nervous system; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ex19del, exon 19 deletion; FDA, US Food and Drug Administration; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; po, by mouth; PS, performance status; qd, once daily; QoL, quality of life; TKI, tyrosine kinase inhibitor; WHO, World Health Organization. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186. 3. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147. 4. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186 \\[protocol\\]. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 6. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147 \\[supplementary appendix\\]. 7. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[protocol\\]. 8. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643. 9. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643 \\[supplementary table\\]. 10. Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A III, eds. _AJCC Cancer Staging Manual_. 7th ed. New York, NY: Springer; 2010. 11. Rami-Porta R, Asamura H, Travis WD, Rusch VW. Lung cancer—major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. _CA Cancer J Clin_. 2017;67(2):138-155. 12. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723. 13. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[supplementary appendix\\]. 14. MacLean M, Luo X, Wang S, Kernstine K, Gerber DE, Xie Y. Outcomes of neoadjuvant and adjuvant chemotherapy in stage 2 and 3 non-small cell lung cancer: an analysis of the National Cancer Database. _Oncotarget_. 2018;9(36):24470-24479.\n\nARs, adverse reactions; CTCAE, Common Terminology Criteria for Adverse Events; NCI, National Cancer Institute; OS, overall survival; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723. 3. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147.\n\nAJCC, American Joint Committee on Cancer; ARs, adverse reactions; CI, confidence interval; CNS, central nervous system; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ex19del, exon 19 deletion; FDA, US Food and Drug Administration; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NE, not estimable; NSCLC, non-small cell lung cancer; OR, odds ratio; OS, overall survival; po, by mouth; qd, once daily; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia; RT, radiotherapy; TKI, tyrosine kinase inhibitor. References: 1. Uramoto H, Tanaka F. Recurrence after surgery in patients with NSCLC. _Transl Lung Cancer Res_. 2014;3(4):242-249. 2. Chouaid C, Danson S, Andreas S, et al. Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study. _Lung Cancer_. 2018;124:310-316. 3. MacLean M, Luo X, Wang S, Kernstine K, Gerber DE, Xie Y. Outcomes of neoadjuvant and adjuvant chemotherapy in stage 2 and 3 non-small cell lung cancer: an analysis of the National Cancer Database. _Oncotarget_. 2018;9(36):24470-24479. 4. Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in patterns of recurrence in early-stage versus locally advanced non-small cell lung cancer. _Ann Thorac Surg_. 2014;98(5):1755-1760. 5. Dong ZY, Zhang JT, Liu SY, et al. EGFR mutation correlates with uninflamed phenotype and weak immunogenicity, causing impaired response to PD-1 blockade in non-small cell lung cancer. _Oncoimmunology_. 2017;6(11):e1356145. 6. Galvez C, Jacob S, Finkelman BS, et al. The role of EGFR mutations in predicting recurrence in early and locally advanced lung adenocarcinoma following definitive therapy. _Oncotarget_. 2020;11(21):1953-1960. 7. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777 \\[supplementary appendix\\]. 8. D'Angelo SP, Janjigian YY, Ahye N, et al. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. _J Thorac Oncol_. 2012;7(12):1815-1822. 9. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 10. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. _J Thorac Oncol_. 2015;10(5):768-777. 11. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. _JAMA_. 2014;311(19):1998-2006. 12. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 13. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186. 14. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147. 15. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage IB-IIIA non–small-cell lung cancer: updated results from the phase III randomized ADAURA trial \\[published online ahead of print January 31, 2023\\]. _J Clin Oncol_. doi:10.1200/JCO.22.02186 \\[protocol\\]. 16. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 17. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. _N Engl J Med_. 2023;389(2):137-147 \\[supplementary appendix\\]. 18. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[protocol\\]. 19. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643. 20. Koch AL, Vellanki PJ, Drezner N, et al. FDA approval summary: osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review. _Clin Cancer Res_. 2021;27(24):6638-6643 \\[supplementary table\\]. 21. Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A III, eds. _AJCC Cancer Staging Manual_. 7th ed. New York, NY: Springer; 2010. 22. Rami-Porta R, Asamura H, Travis WD, Rusch VW. Lung cancer—major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. _CA Cancer J Clin_. 2017;67(2):138-155. 23. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723. 24. Wu YL, Tsuboi M, He J, et al; ADAURA Investigators. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. _N Engl J Med_. 2020;383(18):1711-1723 \\[supplementary appendix\\]. 25. Freeman RK, Ascioti AJ, Dake M, Mahidhara RS. The effects of a multidisciplinary care conference on the quality and cost of care for lung cancer patients. _Ann Thorac Surg_. 2015;100(5):1834-1838. 26. Bilfinger TV, Albano D, Perwaiz M, Keresztes R, Nemesure B. Survival outcomes among lung cancer patients treated using a multidisciplinary team approach. _Clin Lung Cancer_. 2018;19(4):346-351. 27. Wang J, Kuo YF, Freeman J, Goodwin JS. Increasing access to medical oncology consultation in older patients with stage II-IIIA non-small-cell lung cancer. _Med Oncol_. 2008;25(2):125-132. 28. Postmus PE, Kerr KM, Oudkerk M, et al; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. _Ann Oncol_. 2017;28(suppl4):iv1-iv21. 29. Zuccato JA, Ellis PM. Improving referral of patients for consideration of adjuvant chemotherapy after surgical resection of lung cancer. _Curr Oncol_. 2012;19(6):e422-e427. 30. Hirsch FR, Kerr KM, Bunn PA Jr, et al. Molecular and immune biomarker testing in squamous-cell lung cancer: effect of current and future therapies and technologies. _Clin Lung Cancer._ 2018;19(4):331-339.\n\n1L, first-line; 2L, second-line; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NG, nasogastric; NSCLC, non-small cell lung cancer; T790M, exon 20 threonine 790 methionine substitution. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-55578. AstraZeneca Pharmaceuticals LP. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nCI, confidence interval; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.\n\n1L, first-line; AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; EHR, electronic health records; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; G12C, glycine-to-cysteine substitution at codon 12; HER2, human epidermal growth factor receptor; ICI, immune checkpoint inhibitor; ILD, interstitial lung disease; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; ORR, overall response rate; PD-L1, programmed death-ligand 1; QNS, quantity not sufficient; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. 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NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Robert NJ, Espirito JL, Chen L, et al. Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. _Lung Cancer_. 2022;166:197-204. 6. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187 \\[supplementary appendix 2\\]. 7. Data on File. US-42770. EGFR TKI prescription data from Flatiron Health EHR-derived database (included patients who started treatment between October 2017 to April 2020, all data collected online). Ipsos data © Ipsos 2020, all rights reserved. AstraZeneca Pharmaceuticals LP. 8. Oshima Y, Tanimoto T, Yuji K, Tojo A. 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Different incidence of interstitial lung disease according to different kinds of EGFR-tyrosine kinase inhibitors administered immediately before and/or after anti-PD-1 antibodies in lung cancer. _Thorac Cancer_. 2019;10(4):975-979. 13. Kotake M, Murakami H, Naito T, et al. Practical use of osimertinib in Japanese patients with EGFR T790M mutation positive advanced non-small-cell lung cancer \\[abstract\\]. _Ann Oncol_. 2016;27(suppl9):ix147. 14. Keytruda \\[package insert\\]. Whitehouse Station, NJ: Merck & Co., Inc; 2023. 15. Tecentriq \\[package insert\\]. South San Francisco, CA: Genentech Inc.; 2023. 16. Opdivo \\[package insert\\]. Princeton, NJ: Bristol-Myers Squibb Company; 2023. 17. Yervoy \\[package insert\\]. Princeton, NJ: Bristol-Myers Squibb Company; 2023. 18. Libtayo \\[package insert\\]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2023. 19. Lisberg A, Cummings A, Goldman JW, et al. A phase II study of pembrolizumab in EGFR-mutant, PD-L1+, tyrosine kinase inhibitor naïve patients with advanced NSCLC. _J Thorac Oncol_. 2018;13(8):1138-1145. 20. Reck M, Rodríguez-Abreu D, Robinson AG, et al; KEYNOTE-024 Investigators. Pembrolizumab versus chemotherapy for PD-L1–positive non-small-cell lung cancer. _N Engl J Med_. 2016;375(19):1823-1833. 21. Mok TSK, Wu YL, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. _Lancet_. 2019;393(10183):1819-1830. 22. Langer CJ, Gadgeel SM, Borghaei H, et al; KEYNOTE-021 Investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. _Lancet Oncol_. 2016;17(11):1497-1508. 23. Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al; KEYNOTE-189 Investigators. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer. _N Engl J Med_. 2018;378(22):2078-2092. 24. Carbone DP, Reck M, Paz-Ares L, et al; CheckMate 026 Investigators. First-line nivolumab in stage IV or recurrent non-small-cell-lung cancer. _N Engl J Med_. 2017;376(25):2415-2426. 25. Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. _N Engl J Med_. 2018;378(22):2093-2104. 26. Paz-Ares L, Ciuleanu TE, Cobo M, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate LA): an international, randomised, open-label, phase 3 trial \\[published correction appears in _Lancet Oncol_. 2021;22(3):e92\\]. _Lancet Oncol_. 2021;22(2):198-211. 27. West H, McCleod M, Hussein M, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. _Lancet Oncol_. 2019;20(7):924-937. 28. Socinski MA, Jotte RM, Cappuzzo F, et al; IMpower150 Study Group. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. _N Engl J Med_. 2018;378(24):2288-2301. 29. Nishio M, Barlesi F, West H, et al. Atezolizumab plus chemotherapy for first-line treatment of nonsquamous NSCLC: results from the randomized phase 3 IMpower132 trial. _J Thorac Oncol_. 2021;16(4):653-664. 30. Herbst RS, Giaccone G, de Marinis F, et al. Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC. _N Engl J Med_. 2020;383(14):1328-1339. 31. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PDL1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. _Lancet_. 2021;397(10274):592-604. 32. Gogishvili M, Melkadze T, Makharadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. _Nat Med_. 2022;28(11):2374-2380. 33. Johnson ML, Cho BC, Luft A, et al. Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non-small-cell lung cancer: the phase III POSEIDON study. _J Clin Oncol_. 2023;41(6):1213-1227. 34. Lumakras \\[package insert\\]. Thousand Oaks, CA: Amgen Inc.; 2023. 35. Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. _N Engl J Med_. 2021;384(25):2371-2381. 36. Rybrevant \\[package insert\\]. Horsham, PA: Janssen Biotech, Inc.; 2022. 37. ENHERTU \\[package insert\\]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2022. 38. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328. 39. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328 \\[supplemental table\\]. 40. D’Incecco A, Andreozzi M, Ludovini V, et al. PD-1 and PD-L1 expression in molecularly selected non-small-cell lung cancer patients. _Br J Cancer_. 2015;112(1):95-102. 41. Dietel M, Savelov N, Salanova R, et al. Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer: the global, multicenter EXPRESS study. _Lung Cancer_. 2019;134:174-179. 42. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. _J Thorac Oncol_. 2020;15(1):138-143. 43. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. _Clin Cancer Res_. 2019;25(15):4691-4700. 44. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. _JAMA Oncol_. 2019;5(2):173-180. 45. Merker JD, Oxnard GR, Compton C, et al. Circulating tumor DNA analysis in patients with cancer: American Society of Clinical Oncology and College of American Pathologists joint review. _J Clin Oncol_. 2018;36(16):1631-1641.\n\nAEs, adverse events; AUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CR, complete response; ctDNA, circulating tumor DNA; DoR, duration of response; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; MRI, magnetic resonance imaging; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; OR, odds ratio; ORR, overall response rate; OS, overall survival; PET, positron emission tomography; PFS, progression-free survival; PK, pharmacokinetics; po, by mouth; PR, partial response; PS, performance status; qd, once daily; RECIST, Response Evaluation Criteria in Solid Tumors; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor; WHO, World Health Organization. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Ramalingam SS, Vansteenkiste J, Planchard D, et al; FLAURA Investigators. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. _N Engl J Med_. 2020;382(1):41-50. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125. 5. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125 \\[protocol\\]. 6. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 7. Rangachari D, Yamaguchi N, VanderLaan PA, et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. _Lung Cancer_. 2015;88(1):108-111. 8. Reungwetwattana T, Nakagawa K, Cho BC, et al. CNS response to osimertinib versus standard epidermal growth factor receptor tyrosine kinase inhibitors in patients with untreated EGFR-mutated advanced non-small-cell lung cancer. _J Clin Oncol_. 2018;36(33):3290-3297. 9. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125 \\[supplementary appendix\\]. 10. Ballard P, Yates JW, Yang Z, et al. Preclinical comparison of osimertinib with other EGFR-TKIs in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. _Clin Cancer Res_. 2016;22(20):5130-5140. 11. Colclough N, Chen K, Johnström P, Fridén M, McGinnity DF. Building on the success of osimertinib: achieving CNS exposure in oncology drug discovery. _Drug Discov Today_. 2019;24(5):1067-1073. 12. Varrone A, Varnäs K, Jucaite A, et al. A PET study in healthy subjects of brain exposure of 11C-labeled osimertinib—a drug intended for treatment of brain metastases in non-small cell lung cancer. \n_J Cereb Blood Flow Metab_. 2020;40(4):799-807.\n\nALT, alanine aminotransferase; ARs, adverse reactions; AST, aspartate transaminase; CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; ILD, interstitial lung disease; NCI, National Cancer Institute; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia; RTI, respiratory tract infection; TKI, tyrosine kinase inhibitor. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med._ 2018;378(2):113-125.\n\nAUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CTCAE, Common Terminology Criteria for Adverse Events; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; HR, hazard ratio; NA, not applicable; NCI, National Cancer Institute; NSCLC, non-small cell lung cancer; ORR, overall response rate; PFS, progression-free survival; po, by mouth; PS, performance status; qd, once daily; QTc, heart-rate corrected QT interval; QTcF, corrected QT interval by Fridericia; RECIST, Response Evaluation Criteria in Solid Tumors; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor; WHO, World Health Organization. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Mok TS, Wu YL, Ahn MJ, et al; AURA3 Investigators. Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. _N Engl J Med_. 2017;376(7):629-640. 3. cobas® EGFR Mutation Test v2 \\[package insert\\]. Indianapolis, IN: Roche Molecular Systems, Inc.; 2021. 4. Guardant360 CDx \\[package insert\\]. Redwood City, CA: Guardant Health, Inc.; 2023.\n\nEGFR, epidermal growth factor receptor; IO, immunotherapy; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; TKI, tyrosine kinase inhibitor.\n\n1L, first-line; 2L, second-line; APPs, Advanced Practice Providers; AUC, area under the curve; BCRP, breast cancer resistance protein; CRT, chemoradiation therapy; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; CYP, cytochrome P450; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; LVEF, left ventricular ejection fraction; mNSCLC, metastatic non-small cell lung cancer; NG, nasogastric; NSCLC, non-small cell lung cancer; P-GP, P-glycoprotein; q3w, once every 3 weeks; qd, once daily; QTc, heart rate-corrected QT interval; T790M, exon 20 threonine 790 methionine substitution.References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nAR, adverse reaction; AUC, area under the curve; CTCAE, Common Terminology Criteria for Adverse Events; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFRm, epidermal growth factor receptor mutation; NCI, National Cancer Institute; NSCLC, non-small cell lung cancer; po, by mouth; q3w, once every 3 weeks; qd, once daily; QTc, heart rate-corrected QT interval; QTcF, corrected QT interval by Fridericia.References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Planchard D, Jänne PA, Cheng Y, et al. FLAURA2: safety and CNS outcomes of first-line osimertinib ± chemotherapy in EGFRm advanced NSCLC \\[oral presentation\\]. 2023 ESMO Congress; October 20-24, 2023; Madrid, Spain. 3. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[supplementary appendix\\]. 4. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948. 5. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\].\n\n1L, first-line; 2L, second-line; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; LVEF, left ventricular ejection fraction; mNSCLC, metastatic non-small cell lung cancer; NG, nasogastric; NSCLC, non-small cell lung cancer; po, by mouth; q3w, once every 3 weeks; qd, once daily; T790M, exon 20 threonine 790 methionine substitution. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-55578. AstraZeneca Pharmaceuticals LP. 3. Data on File. US-74462. AstraZeneca Pharmaceuticals LP.\n\nAUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; CR, complete response; ctDNA, circulating tumor DNA; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; DoR, duration of response; ECG, electrocardiogram; eCRF, electronic case-report form; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; Ex19del, exon 19 deletion; HR, hazard ratio; ILD, interstitial lung disease; L858R, exon 21 leucine 858 arginine substitution; mOS, median overall survival; mPFS, median progression-free survival; MRI, magnetic resonance imaging; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; PR, partial response; PS, performance status; q3w, once every 3 weeks; qd, once daily; RECIST, Response Evaluation Criteria in Solid Tumors; TKI, tyrosine kinase inhibitor; WHO, World Health Organization.References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948. 3. Valdiviezo N, Okamoto I, Hughes BGM, et al. First-line osimertinib ± platinum-pemetrexed in EGFRm advanced NSCLC: FLAURA2 post-progression outcomes \\[oral presentation\\]. Presented at: 2024 European Lung Cancer Congress; March 20-23, 2024; Prague, Czech Republic. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Jänne PA, Planchard D, Cheng Y, et al. Osimertinib with/without platinum-based chemotherapy as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA2) \\[oral presentation\\]. Presented at: 2023 World Conference on Lung Cancer; September 9-12, 2023; Singapore. 6. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[supplementary appendix\\]. 7. Jänne PA, Planchard D, Kobayashi K, et al. CNS efficacy of osimertinib with or without chemotherapy in epidermal growth factor receptor-mutated advanced non-small-cell lung cancer. _J Clin Oncol_. 2024;42(7):808-820. 8. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\].\n\n1L, first-line; 2L, second-line; CRT, chemoradiotherapy; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; T790M, exon 20 threonine 790 methionine substitution. Reference: 1. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nAUC, area under the curve; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily. Reference: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.\n\n1L, first-line; AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CI, confidence interval; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; EHR, electronic health records; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; Ex19del, exon 19 deletion; G12C, glycine-to-cysteine substitution at codon 12; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; ICI, immune checkpoint inhibitor; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; PD-L1, programmed death-ligand 1; PFS, progression-free survival; QNS, quantity not sufficient; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; SCLC, small cell lung cancer; SEER, Surveillance, Epidemiology, and End Results; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. References: 1. Jordan EJ, Kim HR, Arcila ME, et al. Prospective comprehensive molecular characterization of lung adenocarcinomas for efficient patient matching to approved and emerging therapies. _Cancer Discov_. 2017;7(6):596-609. 2. Gatalica Z, Xiu J, Swensen J, Vranic S. Molecular characterization of cancers with NTRK gene fusions. _Mod Pathol_. 2019;32(1):147-153. 3. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 12, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Robert NJ, Espirito JL, Chen L, et al. Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. _Lung Cancer_. 2022;166:197-204. 6. Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRASG12C somatic mutations across race, sex, and cancer type \\[correspondence\\]. _N Engl J Med_. 2021;384(2):185-187 \\[supplementary appendix 2\\]. 7. Data on File. US-76421. AstraZeneca Pharmaceuticals LP. 8. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328. 9. Mazieres J, Drilon A, Lusque A, et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. _Ann Oncol_. 2019;30(8):1321-1328 \\[supplemental table\\]. 10. Dietel M, Savelov N, Salanova R, et al. Real-world prevalence of programmed death ligand 1 expression in locally advanced or metastatic non–small-cell lung cancer: the global, multicenter EXPRESS study. _Lung Cancer_. 2019;134:174-179. 11. D’Incecco A, Andreozzi M, Ludovini V, et al. PD-1 and PD-L1 expression in molecularly selected non-small-cell lung cancer patients. _Br J Cancer_. 2015;112(1):95-102. 12. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. _J Thorac Oncol_. 2020;15(1):138-143. 13. Lumakras \\[package insert\\]. Thousand Oaks, CA: Amgen Inc.; 2023. 14. Skoulidis F, Li BT, Dy GK, et al. Sotorasib for lung cancers with KRAS p.G12C mutation. _N Engl J Med_. 2021;384(25):2371-2381. 15. ENHERTU \\[package insert\\]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2022. 16. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. _Clin Cancer Res_. 2019;25(15):4691-4700. 17. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. _JAMA Oncol_. 2019;5(2):173-180. 18. Merker JD, Oxnard GR, Compton C, et al. Circulating tumor DNA analysis in patients with cancer: American Society of Clinical Oncology and College of American Pathologists joint review. _J Clin Oncol_. 2018;36(16):1631-1641. 19. Peters S, Bexelius C, Munk V, Leighl N. The impact of brain metastasis on quality of life, resource utilization and survival in patients with non-small-cell lung cancer. _Cancer Treat Rev_. 2016;45:139-162. 20. Su PL, Wu YL, Chang WY, et al. Preventing and treating brain metastases with three first-line EGFR-tyrosine kinase inhibitors in patients with EGFR mutation-positive advanced non-small cell lung cancer. _Ther Adv Med Oncol_. 2018;10:1758835918797589. 21. Koyama N, Watanabe Y, Iwai Y, et al. Distinct benefit of overall survival between patients with non-small-cell lung cancer harboring EGFR exon 19 deletion and exon 21 L858R substitution. _Chemotherapy_. 2017;62(3):151-158. 22. Sheng M, Wang F, Zhao Y, et al. Comparison of clinical outcomes of patients with non-small-cell lung cancer harbouring epidermal growth factor receptor exon 19 or exon 21 mutations after tyrosine kinase inhibitors treatment: a meta-analysis. _Eur J Clin Pharmacol_. 2016;72(1):1-11. 23. Li J, Zhu H, Sun L, Xu W, Wang X. Prognostic value of site-specific metastases in lung cancer: a population based study. _J Cancer_. 2019;10(14):3079-3086. 24. Li L, Luo S, Lin H, et al. Correlation between EGFR mutation status and the incidence of brain metastases in patients with non-small cell lung cancer. _J Thorac Dis_. 2017;9(8):2510-2520. 25. Rangachari D, Yamaguchi N, VanderLaan PA, et al. Brain metastases in patients with EGFR-mutated or ALK rearranged non-small-cell lung cancers. _Lung Cancer_. 2015;88(1):108-111.\n\n1L, first-line; 2L, second-line; AUC, area under the curve; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; CRT, chemoradiotherapy; DFS, disease-free survival; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; HR, hazard ratio; mNSCLC, metastatic non-small cell lung cancer; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor. Reference: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.\n\nALK, anaplastic lymphoma kinase; BRAF, v-raf murine sarcoma viral oncogene homolog B1; cCRT, concurrent chemoradiotherapy; CNS, central nervous system; CRT, chemoradiotherapy; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; FDA, US Food and Drug Administration; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; TKI, tyrosine kinase inhibitor.References: 1. Park SE, Noh JM, Kim YJ, et al. EGFR mutation is associated with short progression-free survival in patients with stage III non-squamous cell lung cancer treated with concurrent chemoradiotherapy. _Cancer Res Treat_. 2019;51(2):493-501. 2. Kim H, Park S, Jung HA, et al. EGFR mutation–positive unresectable stage III non-squamous lung cancer is associated with a high incidence of brain metastasis. _Cancer Res Treat_. 2023;55(2):498-505. 3. Tanaka K, Hida T, Oya Y, et al. EGFR mutation impact on definitive concurrent chemoradiation therapy for inoperable stage III adenocarcinoma. _J Thorac Oncol_. 2015;10(12):1720-1725. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 6. Aggarwal C, Bubendorf L, Cooper WA, et al. Molecular testing in stage I-III non-small cell lung cancer: approaches and challenges. _Lung Cancer_. 2021;162:42-53. 7. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442. 8. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\].\n\nAJCC/UICC, American Joint Committee on Cancer/Union for International Cancer Control; ALK, anaplastic lymphoma kinase; BICR, blinded independent central review; BRAF, v-raf murine sarcoma viral oncogene homolog B1; cCRT, concurrent chemoradiotherapy; CI, confidence interval; CNS, central nervous system; CR, complete response; CRT, chemoradiotherapy; CT, computed tomography; DoR, duration of response; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; Ex19del, exon 19 deletion; HR, hazard ratio; ILD, interstitial lung disease; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mPFS, median progression-free survival; MRI, magnetic resonance imaging; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; sCRT, sequential chemoradiotherapy; SD, stable disease; TKI, tyrosine kinase inhibitor; WHO PS, World Health Organization performance status. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597. 3. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597 \\[supplementary appendix\\]. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597 \\[protocol\\]. 6. Aggarwal C, Bubendorf L, Cooper WA, et al. Molecular testing in stage I-III non-small cell lung cancer: approaches and challenges. _Lung Cancer_. 2021;162:42-53. 7. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442.\n\nARs, adverse reactions; CPK, creatine phosphokinase; CTCAE, Common Terminology Criteria for Adverse Events; ILD, interstitial lung disease; NCI, National Cancer Institute; QTc, heart rate-corrected QT interval. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med._ 2024;391(7):585-597.\n\nALK, anaplastic lymphoma kinase; BICR, blinded independent central review; BRAF, v-raf murine sarcoma viral oncogene homolog B1; cCRT, concurrent chemoradiotherapy; CI, confidence interval; CNS, central nervous system; CR, complete response; CRT, chemoradiotherapy; CTCAE, Common Terminology Criteria for Adverse Events; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; ERBB2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2; Ex19del, exon 19 deletion; FDA, US Food and Drug Administration; HR, hazard ratio; ILD, interstitial lung disease; KRAS, V-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homolog; L858R, exon 21 leucine 858 arginine substitution; MDT, multidisciplinary team; MET, mesenchymal-epithelial transition; mPFS, median progression-free survival; NC, not calculable; NCCN, National Comprehensive Cancer Network® (NCCN®); NCI, National Cancer Institute; NE, not estimable; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; QTc, heart rate-corrected QT interval; RECIST, Response Evaluation Criteria in Solid Tumors; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1 receptor tyrosine kinase; SD, stable disease; TKI, tyrosine kinase inhibitor. References: 1. Park SE, Noh JM, Kim YJ, et al. EGFR mutation is associated with short progression-free survival in patients with stage III non-squamous cell lung cancer treated with concurrent chemoradiotherapy. _Cancer Res Treat._ 2019;51(2):493-501. 2. Kim H, Park S, Jung HA, et al. EGFR mutation–positive unresectable stage III non-squamous lung cancer is associated with a high incidence of brain metastasis. _Cancer Res Treat._ 2023;55(2):498-505. 3. Tanaka K, Hida T, Oya Y, et al. EGFR mutation impact on definitive concurrent chemoradiation therapy for inoperable stage III adenocarcinoma. _J Thorac Oncol._ 2015;10(12):1720-1725. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 6. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948 \\[protocol\\]. 7. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med_. 2024;391(7):585-597. 8. Lu S, Kato T, Dong X, et al; LAURA Investigators. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. _N Engl J Med_. 2024;391(7):585-597 \\[supplementary appendix\\]. 9. Aggarwal C, Bubendorf L, Cooper WA, et al. Molecular testing in stage I-III non-small cell lung cancer: approaches and challenges. _Lung Cancer_. 2021;162:42-53. 10. Anand K, Phung TL, Bernicker EH, Cagle PR, Olsen RJ, Thomas JS. Clinical utility of reflex ordered testing for molecular biomarkers in lung adenocarcinoma. _Clin Lung Cancer_. 2020;21(5):437-442.\n\n1L, first-line; 2L, second-line; CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; mNSCLC, metastatic non-small cell lung cancer; NCI, National Cancer Institute; NG, nasogastric; NSCLC, non-small cell lung cancer; QTc, heart rate-corrected QT interval; T790M, exon 20 threonine 790 methionine substitution. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Data on File. US-89546. AstraZeneca Pharmaceuticals LP.\n\nEGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; L858R, exon 21 leucine 858 arginine substitution; NSCLC, non-small cell lung cancer; PET, positron emission tomography; PK, pharmacokinetics; T790M, exon 20 threonine 790 methionine substitution; WT, wild-type. References: 1. TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. _N Engl J Med_. 2018;378(2):113-125. 3. Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. _Cancer Discov_. 2014;4(9):1046-1061. 4. Finlay MR, Anderton M, Ashton S, et al. Discovery of a potent and selective EGFR inhibitor (AZD9291) of both sensitizing and T790M resistance mutations that spares the wild type form of the receptor. _J Med Chem_. 2014;57(20):8249-8267.\n\nRead More Read Less\n\nAstraZeneca Medicines\n---------------------\n\n* * *\n\n* [Contact Us](#popup-1654774330030)\n* [AstraZeneca US Corporate Site](https://www.astrazeneca-us.com)\n* [AstraZeneca Medical Information Support](https://medicalinformation.astrazeneca-us.com/)\n* [Privacy Notice](https://www.azprivacy.astrazeneca.com)\n* [Cookie Notice](https://us-cookienotice.astrazeneca.com/)\n* [Legal Statement](https://www.astrazeneca-us.com/legal-notice.html)\n* [Site Map](/sitemap.html)\n* [Prescribing Information](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1)\n* [Your Privacy Choices](https://do-not-sell-my-personal-information.astrazeneca.com/)![Privacy Option Icon](https://www.astrazeneca.com/content/dam/az/privacyoptions123x59.png)\n* Consumer Health Data Privacy Notice\n* [Find us on](https://www.youtube.com/channel/UCQ0-tofGVEVr_ttn_ATpyKw/videos)\n\n![United States flag icon](/content/dam/open-digital/tagrisso-hcp/us/en/global/flag-icon.png)This product information is intended for US Healthcare Professionals only.\n\nTAGRISSO is a registered trademark of the AstraZeneca group of companies.\n\n©2024 AstraZeneca. 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The information these cookies collect is aggregated and in some instances limited identifiable data may be collected.\n\nDetailed description of cookies categorised as: Performance and Operational Cookies.\n\nCookie\n\nExpiry\n\nDomain\n\nCompany\n\nPurpose\n\nCookieeverest\\_g\\_v2\n\nExpiry2 years\n\nDomaineveresttech.net\n\nCompanyAdobe Inc.\n\nPurposeAnalytics\n\nThese cookies provide feedback on the effectiveness of the advertising displayed on our site and helps show you offers which may be of interest to you.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nThese cookies provide feedback on the effectiveness of the advertising displayed on our site and helps show you offers which may be of interest to you.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookieeverest\\_session\\_v2\n\nExpirySession\n\nDomaineveresttech.net\n\nCompanyAdobe Inc.\n\nPurposeAnalytics\n\nThese cookies provide feedback on the effectiveness of the advertising displayed on our site and helps show you offers which may be of interest to you.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nThese cookies provide feedback on the effectiveness of the advertising displayed on our site and helps show you offers which may be of interest to you.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookietest\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanyAdobe Inc.\n\nPurposeAnalytics\n\nInternal cookie written by Adobe Analytics to test browser cookie support.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nInternal cookie written by Adobe Analytics to test browser cookie support.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookieAMCVS\\__\\*_AdobeOrg\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanyAdobe Analytics, Adobe Inc.\n\nPurposeAnalytics\n\nSession cookie with Adobe. It indicates that a session has been initialized. The organisation ID helps Adobe to only analyse traffic from legitimate websites.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nSession cookie with Adobe. It indicates that a session has been initialized. The organisation ID helps Adobe to only analyse traffic from legitimate websites.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookieAMCV\\__\\*_AdobeOrg\n\nExpiry2 years\n\nDomaintagrissohcp.com\n\nCompanyAdobe Analytics, Adobe Inc.\n\nPurposeAnalytics\n\nHelps Adobe to only analyse traffic from legitimate websites.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nHelps Adobe to only analyse traffic from legitimate websites.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookiegpv\\_pn\n\nExpiry30 minutes\n\nDomaintagrissohcp.com\n\nCompanyAdobe Analytics, Adobe Inc.\n\nPurposeAnalytics\n\nThis cookie is set and read by the Adobe Analytics JavaScript code when the page is loaded. Captures Adobe Analytics page name. No Personally Identifiable Information collected.\n\n\\+ ▼\n\nThis cookie is set and read by the Adobe Analytics JavaScript code when the page is loaded. Captures Adobe Analytics page name. No Personally Identifiable Information collected.\n\nCookieaam\\_uuid\n\nExpiry1 month\n\nDomaintagrissohcp.com\n\nCompanyAdobe Audience Manager, Adobe Inc.\n\nPurposeAnalytics\n\nAudience Manager sets this cookie to assign a unique ID to a site visitor. The cookie helps Audience Manger perform basic functions such as visitor identification, ID synchronization, segmentation, modeling, reporting, etc.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nAudience Manager sets this cookie to assign a unique ID to a site visitor. The cookie helps Audience Manger perform basic functions such as visitor identification, ID synchronization, segmentation, modeling, reporting, etc.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookiedemdex\n\nExpiry2 years\n\nDomaindemdex.net\n\nCompanyAdobe Media Optimizer, Adobe Inc.\n\nPurposeAnalytics\n\nUsed to recognize a returning visitor, build unique audience profiles and deliver targeted messages using Adobe Analytics.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nUsed to recognize a returning visitor, build unique audience profiles and deliver targeted messages using Adobe Analytics.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookiedextp\n\nExpiry6 months\n\nDomaindemdex.net\n\nCompanyAdobe Media Optimizer, Adobe Inc.\n\nPurposeAnalytics\n\nAdobe Audience Manager sets this cookie to record the last time it made a data synchronization call.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nAdobe Audience Manager sets this cookie to record the last time it made a data synchronization call.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookiedpm\n\nExpiry2 years\n\nDomaindpm.demdex.net\n\nCompanyAdobe Media Optimizer, Adobe Inc.\n\nPurposeAnalytics\n\nUsed to help Adobe Audience Manager perform basic functions such as visitor identification, ID synchronization, segmentation, modelling, reporting, etc\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\n\\+ ▼\n\nUsed to help Adobe Audience Manager perform basic functions such as visitor identification, ID synchronization, segmentation, modelling, reporting, etc\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy/policy.html)\n\nCookie\\_clsk\n\nExpiry1 day\n\nDomaintagrissohcp.com\n\nCompanyClarity, Microsoft Corporation\n\nPurposeAnalytics\n\nConnects multiple page views by a user into a single Clarity session recording.\n\n* [Microsoft Corporation](https://www.microsoft.com/) - [Privacy Policy (Microsoft Corporation)](https://privacy.microsoft.com/en-us/privacystatement)\n\n\\+ ▼\n\nConnects multiple page views by a user into a single Clarity session recording.\n\n* [Microsoft Corporation](https://www.microsoft.com/) - [Privacy Policy (Microsoft Corporation)](https://privacy.microsoft.com/en-us/privacystatement)\n\nCookie\\_ga\n\nExpiry2 years\n\nDomaintagrissohcp.com\n\nCompanyGoogle Analytics, Google LLC\n\nPurposeAnalytics\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\n\\+ ▼\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\nCookie\\_gat\\_tealium\\_0\n\nExpiry1 minute\n\nDomaintagrissohcp.com\n\nCompanyGoogle Analytics, Google LLC\n\nPurposeAnalytics\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\n\\+ ▼\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\nCookie\\_ga\\__\\*_\n\nExpiry2 years\n\nDomaintagrissohcp.com\n\nCompanyGoogle Analytics, Google LLC\n\nPurposeAnalytics\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\n\\+ ▼\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\nCookie\\_gid\n\nExpiry1 day\n\nDomaintagrissohcp.com\n\nCompanyGoogle Analytics, Google LLC\n\nPurposeAnalytics\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\n\\+ ▼\n\nA unique identifier given to each browser to track user interactions with the website.\n\n* [Google LLC](https://www.google.com/) - [Privacy Policy (Google LLC)](https://policies.google.com/privacy)\n\nCookies\\_cc\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nStores whether cookies are enabled, on behalf of the SiteCatalyst Analytics platform.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nStores whether cookies are enabled, on behalf of the SiteCatalyst Analytics platform.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_getDaysSinceLastVisit\n\nExpiry3 years\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: getDaysSinceLastVisit\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: getDaysSinceLastVisit\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_getDaysSinceLastVisit\\_s\n\nExpiry3 years\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: getDaysSinceLastVisit\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: getDaysSinceLastVisit\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_getNewRepeat\n\nExpiry30 days\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nDetermines whether a visitor is a new visitor or a repeat visitor, and captures this information in an Analytics variable.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nDetermines whether a visitor is a new visitor or a repeat visitor, and captures this information in an Analytics variable.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_invisit\n\nExpiry30 minutes\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nThis cookie is used by an Omniture plugin to count the visit numbers per month for a specific user of the web page.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nThis cookie is used by an Omniture plugin to count the visit numbers per month for a specific user of the web page.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_plt\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: getPageLoadTime, to store the time, in seconds, that the previous page took to load.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: getPageLoadTime, to store the time, in seconds, that the previous page took to load.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_pltp\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: getPageLoadTime, to store the time, in seconds, that the previous page took to load.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: getPageLoadTime, to store the time, in seconds, that the previous page took to load.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_ppv\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nStores the percentage of the page that was displayed vertically to the end user.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nStores the percentage of the page that was displayed vertically to the end user.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_pvs\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: getPageVisibility\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: getPageVisibility\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_tp\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: Adobe Consulting Plugin\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: Adobe Consulting Plugin\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_tps\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nSet by the optional plugin to SiteCatalyst: getPageVisibility\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nSet by the optional plugin to SiteCatalyst: getPageVisibility\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\nCookies\\_vnum\n\nExpiry30 days\n\nDomaintagrissohcp.com\n\nCompanySiteCatalyst, Adobe Inc.\n\nPurposeAnalytics\n\nEnables Visit Number By Month tracking for the SiteCatalyst Analytics platform by recording how you arrived at the site.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n\\+ ▼\n\nEnables Visit Number By Month tracking for the SiteCatalyst Analytics platform by recording how you arrived at the site.\n\n* [Adobe Inc.](https://www.adobe.com/) - [Privacy Policy (Adobe Inc.)](https://www.adobe.com/privacy.html)\n\n28\n\nMarketing and Targeted Advertising Cookies\n\nConsent for: Marketing and Targeted Advertising Cookies\n\nThese cookies are used to track our visitors browsing habits and activity across our websites. They can be used to build up a profile of search and/or browsing history for every visitor. Identifiable or unique data may be collected which enables us to show you relevant/personalized marketing content. We do not store directly personal information, but information that uniquely identify your browser and internet device and use this to display targeted advertising and/or share this data with third parties for the same purpose. If you do not allow these cookies, you will experience less personalized marketing content and targeted advertising.\n\nDetailed description of cookies categorised as: Marketing and Targeted Advertising Cookies.\n\nCookie\n\nExpiry\n\nDomain\n\nCompany\n\nPurpose\n\nCookiedmd-sid4 (x 2)\n\nExpirySession\n\nDomainwww.tagrissohcp.com\n\nCompanyDMD Marketing Corp.\n\nPurposeAdvertising\n\nHealthcare communications and marketing\n\n* [DMD Marketing Corp.](https://www.dmdconnects.com/) - [Privacy Policy (DMD Marketing Corp.)](https://www.dmdconnects.com/dmd-privacy-policy)\n\n\\+ ▼\n\nHealthcare communications and marketing\n\n* [DMD Marketing Corp.](https://www.dmdconnects.com/) - [Privacy Policy (DMD Marketing Corp.)](https://www.dmdconnects.com/dmd-privacy-policy)\n\nCookiedmd-tag (x 3)\n\nExpiry1 year, 1 month\n\nDomainwww.tagrissohcp.com\n\nCompanyDMD Marketing Corp.\n\nPurposeAdvertising\n\nHealthcare communications and marketing\n\n* [DMD Marketing Corp.](https://www.dmdconnects.com/) - [Privacy Policy (DMD Marketing Corp.)](https://www.dmdconnects.com/dmd-privacy-policy)\n\n\\+ ▼\n\nHealthcare communications and marketing\n\n* [DMD Marketing Corp.](https://www.dmdconnects.com/) - [Privacy Policy (DMD Marketing Corp.)](https://www.dmdconnects.com/dmd-privacy-policy)\n\nCookieuuid\n\nExpiry90 days\n\nDomaininnovid.com\n\nCompanyInnovid\n\nPurposeAdvertising\n\nThis cookie is used to optimize ad relevance by collecting visitor data from different websites - this exchange of visitor data is typically provided by a third party data center or ad exchange service\n\n* [Innovid](https://www.innovid.com/) - [Privacy Policy (Innovid)](https://www.innovid.com/privacy-policy/)\n\n\\+ ▼\n\nThis cookie is used to optimize ad relevance by collecting visitor data from different websites - this exchange of visitor data is typically provided by a third party data center or ad exchange service\n\n* [Innovid](https://www.innovid.com/) - [Privacy Policy (Innovid)](https://www.innovid.com/privacy-policy/)\n\nCookieliveRampRepeatVisitor\n\nExpirySession\n\nDomaintagrissohcp.com\n\nCompanyLiveRamp, Inc.\n\nPurposeAdvertising\n\nCollects anonymous data relating to browsing navigation. Used by advertising platform LiveRamp who work with online partners to build advertisements for their website visitors and with publishers to display personalized advertisements.\n\n* [LiveRamp, Inc.](https://liveramp.com/) - [Privacy Policy (LiveRamp, Inc.)](https://liveramp.com/privacy/)\n\n\\+ ▼\n\nCollects anonymous data relating to browsing navigation. Used by advertising platform LiveRamp who work with online partners to build advertisements for their website visitors and with publishers to display personalized advertisements.\n\n* [LiveRamp, Inc.](https://liveramp.com/) - [Privacy Policy (LiveRamp, Inc.)](https://liveramp.com/privacy/)\n\nCookieliveRampSesssionID\n\nExpiry30 minutes\n\nDomaintagrissohcp.com\n\nCompanyLiveRamp, Inc.\n\nPurposeAdvertising\n\nCollects anonymous data relating to browsing navigation. Used by advertising platform LiveRamp who work with online partners to build advertisements for their website visitors and with publishers to display personalized advertisements.\n\n* [LiveRamp, Inc.](https://liveramp.com/) - [Privacy Policy (LiveRamp, Inc.)](https://liveramp.com/privacy/)\n\n\\+ ▼\n\nCollects anonymous data relating to browsing navigation. Used by advertising platform LiveRamp who work with online partners to build advertisements for their website visitors and with publishers to display personalized advertisements.\n\n* [LiveRamp, Inc.](https://liveramp.com/) - [Privacy Policy (LiveRamp, Inc.)](https://liveramp.com/privacy/)\n\nCookieMR\n\nExpiry1 week\n\nDomainc.clarity.ms\n\nCompanyMicrosoft\n\nPurposeAdvertising\n\nRegisters a unique ID that identifies and recognises the user. Is used for targeted advertising.\n\n* [Microsoft](https://www.microsoft.com/) - [Privacy Policy (Microsoft)](https://privacy.microsoft.com/en-gb)\n\n\\+ ▼\n\nRegisters a unique ID that identifies and recognises the user. 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Please follow the instructions below, from the web browser manufacturers directly, to configure your browser settings\\*.\n\n* [Microsoft Edge](https://support.microsoft.com/en-us/windows/manage-cookies-in-microsoft-edge-view-allow-block-delete-and-use-168dab11-0753-043d-7c16-ede5947fc64d)\n* [Google Chrome](https://support.google.com/chrome/answer/95647?hl=en)\n* [Apple Safari](https://support.apple.com/en-gb/guide/safari/sfri11471/mac)\n* [Mozilla Firefox](https://support.mozilla.org/en-US/kb/enhanced-tracking-protection-firefox-desktop?redirectslug=enable-and-disable-cookies-website-preferences&redirectlocale=en-US)\n\n_\\* These links are to third party sites, over which we have no control – no liability can be claimed if they are inaccurate._\n\nLast updated 2025-10-26[Powered by Digital Control Room](https://www.digitalcontrolroom.com/)\n\n \n\nValidating...\n-------------\n\n#### Welcome to the AstraZeneca Medicines Site\n\n![Tagrisso-Logo](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/tagrisso_logo.png)\n\nIn the first-line treatment of locally advanced or metastatic EGFRm NSCLC\n\n![](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/new_flaura_data.png)\n\nLongest reported mPFS and mOS  with TAGRISSO + chemotherapy\\*\n-------------------------------------------------------------\n\nINVESTIGATOR-ASSESSED mPFS (PRIMARY ENDPOINT)\n\n**25.5 months** (95% CI: 24.7, NE) for **TAGRISSO + CT (pem/plat)†** vs **16.7 months** (95% CI: 14.1, 21.3) for **TAGRISSO; HR=0.62** (95% CI: 0.49, 0.79); _P_<0.0001; N=5571‡\n\nOVERALL SURVIVAL DATA (SECONDARY ENDPOINT)\n\n![](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/FPO.png)\n\n4\n\nyears\n\nmedian overall survival§\n------------------------\n\n**47.5 months** (95% CI: 41.0, NC) for **TAGRISSO + CT (pem/plat)†** vs **37.6 months** (95% CI: 33.2, 43.2) for **TAGRISSO2**\n\n### STATISTICALLY SIGNIFICANT OVERALL SURVIVAL2\n\n![](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/km_curve_wfpo_desktop.png)\n\nreduction in risk of death\n\n![23graphic](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/23p_graphic.png)\n\n* OS rates at 24, 36, and 48 months were not powered to show statistical significance\n* Median follow-up for OS (censored patients): 51.2 months (0.2, 60.4) for TAGRISSO + CT (pem/plat) and 51.3 months (0.1, 60.1) for TAGRISSO\n\nreduction in risk of death\n\n![graph](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/mobile/71-45_V2.Graphic.png)\n\nTAGRISSO + CT (pem/plat) has the longest reported mPFS and the longest mOS in first-line EGFRm mNSCLC1,2\n\n[\n\nHEAR FROM Dr JÄNNE ON THE RESULTS\n\n![download button](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/download_button.png)](https://www.tagrissohcp.com/metastatic/flaura2/video-library.html)\n\n[\n\nDownload the survival data\n\n![download button](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/arrow_down.png)](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/FLAURA2_OS_Day_0_Flashcard_Digital.pdf)\n\n**FLAURA2 study design:** Phase 3, open-label, randomized global trial in 557 patients with locally advanced or metastatic EGFRm (exon 19 deletions or exon 21 L858R mutations) NSCLC without prior systemic treatment for advanced disease. Patients were randomized 1:1 to either TAGRISSO monotherapy (n=278) or TAGRISSO + CT (pem/plat) (n=279) and treated until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed PFS.1,3\n\n\\*TAGRISSO + chemotherapy reported the longest statistically significant mOS of an FDA-approved regimen for 1L treatment of patients with EGFRm (exon 19 or exon 21 L858R) locally advanced or metastatic NSCLC.1,2\n\n†TAGRISSO + CT (pem/plat) dosing: In cycles 1-4, TAGRISSO 80 mg po qd + pemetrexed (500 mg/m2) q3w + cisplatin (75 mg/m2) or carboplatin (AUC 5) q3w; in cycles 5+, TAGRISSO 80 mg po qd + pemetrexed maintenance (500 mg/m2) q3w until disease progression or unacceptable toxicity. TAGRISSO dosing: 80 mg po qd until disease progression or unacceptable toxicity.1\n\n‡Overall PFS maturity by IA was 51%.3\n\n§Overall OS maturity was 57%.2\n\nCT (pem/plat), pemetrexed plus platinum-based chemotherapy.\n\n### IMPORTANT SAFETY INFORMATION\n\n* There are no contraindications for TAGRISSO\n* TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy (CRT); 0.4% of cases were fatal. In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal. For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed\n* TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia\n* TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum- based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO\n* Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist\n* Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed\n* Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity\n* Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated\n* Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose\n* Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose\n* Most common (≥20%) adverse reactions, including laboratory abnormalities, were:\n * TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine\n\n### INDICATION\n\n* TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n\nFor additional information, please see the complete [Prescribing Information](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1), including Patient Information for TAGRISSO.\n\n_You may_ [report side effects related to AstraZeneca products](https://us-aereporting.astrazeneca.com/adverse-events.html) [![](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/arrow-icon.png)](https://us-aereporting.astrazeneca.com/adverse-events.html).\n\n1L, first-line; AUC, area under the curve; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFRm, epidermal growth factor receptor mutation; FDA, US Food and Drug Administration; HR, hazard ratio; IA, investigator assessment; L858R, exon 21 leucine 858 arginine substitution; mOS, median overall survival; mPFS, median progression-free survival; NC, not calculable; NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily.\n\n**References: 1.** TAGRISSO \\[package insert\\]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. **2.** Planchard D, Jänne PA, Kobayashi K, et al. First-line osimertinib + chemotherapy versus osimertinib monotherapy in EGFRm advanced NSCLC: FLAURA2 final overall survival \\[oral presentation\\]. Presented at: World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. **3.** Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. _N Engl J Med_. 2023;389(21):1935-1948.\n\n![](/content/dam/open-digital/tagrisso-hcp/us/en/global/flag-icon.png)This product information is intended for US Healthcare Professionals only.\n\nTAGRISSO is a registered trademark of the AstraZeneca group of companies.\n\n©2025 AstraZeneca. All rights reserved. US-101630 Last Updated 9/25\n\n[![AstraZeneca logo](/content/dam/open-digital/tagrisso-hcp/us/en/global/Astrazeneca-logo.png \"AstraZeneca logo\")](https://www.astrazeneca-us.com/)\n\nIMPORTANT SAFETY INFORMATION\n\n[![Show ISI](/content/dam/open-digital/tagrisso-hcp/us/en/laura-now-approved/dropdown-btn.png)](#isi-sec)\n\n* There are no contraindications for TAGRISSO\n* TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy; 0.4% of cases were fatal\n\n### Important Safety Information\n\n* There are no contraindications for TAGRISSO\n* TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy (CRT); 0.4% of cases were fatal. In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal. For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed\n* TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia\n* TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum- based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO\n* Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist\n* Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed\n* Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity\n* Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated\n* Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose\n* Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose\n* Most common (≥20%) adverse reactions, including laboratory abnormalities, were:\n * TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine\n\n### INDICATION\n\n* TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test\n\nFor additional information, please see the complete [Prescribing Information](https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1), including Patient Information for TAGRISSO.\n\n_You may_ [report side effects related to AstraZeneca products](https://us-aereporting.astrazeneca.com/adverse-events.html) [![](/content/dam/open-digital/tagrisso-hcp/us/en/flaura_os/desktop/arrow-icon.png)](https://us-aereporting.astrazeneca.com/adverse-events.html).\n\nI am a health professional\n\n 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