{"entity":{"id":"osimertinib","kind":"drug","name":"Osimertinib","aka":[],"tldr":"Osimertinib (Tagrisso) is the standard pill for EGFR-mutant lung cancer, now also given after surgery and with chemotherapy or after chemoradiation.","summary":"Osimertinib is an irreversible third-generation EGFR tyrosine kinase inhibitor that spares wild-type EGFR, covers the T790M resistance mutation and penetrates the brain, taken as 80 mg once daily. It is the standard first-line pill for EGFR-mutant NSCLC after FLAURA showed an overall survival benefit, and its reach has widened: ADAURA (adjuvant, up to 3 years, OS HR 0.49 with 5-year OS 88% versus 78%), FLAURA2 (with chemotherapy, PFS 25.5 versus 16.7 months and OS HR 0.77 in 2025) and LAURA (after chemoradiation in stage III). Diarrhoea and rash affect over half of patients but are rarely severe; interstitial lung disease (4%) needs vigilance. It is now challenged first line by amivantamab plus lazertinib (MARIPOSA), and whether every patient should receive added chemotherapy is unsettled. For a newcomer: the drug that made EGFR-mutant lung cancer a long-term treatable disease.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Osimertinib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Osimertinib"},{"label":"NICE TA654: osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta654"},{"label":"NICE TA1043: osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection","url":"https://www.nice.org.uk/guidance/ta1043"},{"label":"NICE TA1060: osimertinib with pemetrexed and platinum-based chemotherapy for untreated EGFR mutation-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1060"},{"label":"NICE TA1156: osimertinib for EGFR mutation-positive unresectable locally advanced non-small-cell lung cancer after platinum-based chemoradiotherapy","url":"https://www.nice.org.uk/guidance/ta1156"}],"tags":[],"related":["egfr-exon-19-deletion","egfr-l858r","egfr-t790m"],"cancers":["nsclc","egfr-mutant-nsclc","resectable-nsclc","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["adaura","flaura2","nct06350097","nct04351555","nct06838273","nct05120349","nct06670196","nct02411448","nct07640789","nct06417814","nct07642024","nct04765059","nct04606771","nct06498986","nct05801029","nct05880706","nct07229729","nct07622186","nct07079475","nct04868877","nct05816252","nct07329322","nct05546866","nct07206498","nct04665206","nct07669779","nct03944772","nct06574347","nct04486833","nct05785741","nct03778229","nct06895928","nct05261399","nct03381274","nct06194448","nct03040973","nct03833154","nct07295821","nct05948813","nct05629234","nct06970639","nct06618287","nct06391944","nct05526755","nct06868485","flaura","aura3","laura"],"people":[],"bottlenecks":[],"keyPapers":["paper-flaura-nejm-2018","paper-flaura2-long-term-safety-lung-cancer-2026","paper-mariposa-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"brand":"Tagrisso","modality":"Small-molecule kinase inhibitor (EGFR)","mechanism":"Irreversible third-generation EGFR TKI sparing wild-type EGFR; active against T790M; CNS penetrant.","approvals":[{"region":"US","year":2015,"indication":"EGFR T790M NSCLC"},{"region":"US","year":2018,"indication":"First-line EGFR-mutant NSCLC"},{"region":"US","year":2020,"indication":"Adjuvant EGFR-mutant NSCLC"},{"region":"England (NICE)","year":2020,"indication":"Untreated locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer","note":"TA654, published 14 October 2020, recommends osimertinib within its marketing authorisation subject to the commercial arrangement."},{"region":"England (NICE)","year":2020,"indication":"EGFR T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer after a first-line EGFR inhibitor","note":"TA653, published 14 October 2020, subject to the commercial arrangement."},{"region":"England (NICE)","year":2025,"indication":"Adjuvant treatment of stage IB to IIIA EGFR exon 19 deletion or L858R non-small-cell lung cancer after complete resection","note":"TA1043, published 26 February 2025, recommends it only if osimertinib is stopped at 3 years, or earlier on recurrence or unacceptable toxicity. It replaced a managed access agreement whose data, from the ADAURA trial and from NHS use in England, were reviewed in the appraisal."},{"region":"England (NICE)","year":2025,"indication":"Untreated advanced EGFR mutation-positive non-small-cell lung cancer, with pemetrexed and platinum-based chemotherapy","note":"TA1060, published 8 May 2025, subject to the commercial arrangement (FLAURA2)."},{"region":"England (NICE)","year":2026,"indication":"Unresectable stage III EGFR mutation-positive non-small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy","note":"TA1156, published 21 May 2026 (LAURA); must be funded in England within 90 days of publication."}],"mechanismSteps":["Oral drug is absorbed and reaches the tumour","Binds the ATP pocket (or allosteric site) of mutant EGFR (including T790M)","Phosphorylation of downstream substrates stops","Covalent bond to Cys797 blocks ATP binding; wild-type EGFR is spared","Oncogene-addicted cells arrest and undergo apoptosis"],"dosing":{"route":"Oral","schedule":"80 mg once daily with or without food; adjuvant up to 3 years","modifications":"Reduce to 40 mg for QTc >500 ms or grade 3 toxicity; permanently discontinue for ILD","monitoring":"ECG and electrolytes in at-risk patients; LVEF; respiratory symptoms","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7"},"toxicity":[{"event":"Diarrhoea","anyGradePct":58,"grade3PlusPct":2.2,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Rash","anyGradePct":58,"grade3PlusPct":1.1,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Dry skin","anyGradePct":36,"grade3PlusPct":0.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Nail toxicity","anyGradePct":35,"grade3PlusPct":0.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Stomatitis","anyGradePct":32,"grade3PlusPct":0.7,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Fatigue","anyGradePct":21,"grade3PlusPct":1.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Decreased appetite","anyGradePct":20,"grade3PlusPct":2.5,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"Interstitial lung disease","anyGradePct":4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"0.4% fatal; higher after chemoradiation"},{"event":"Cardiomyopathy","anyGradePct":3.8,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"},{"event":"QTc >500 ms","anyGradePct":1.1,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","note":"FLAURA"}],"access":[{"country":"US","reimbursement":"Medicare Part D (oral); commercial plans per formulary, often with prior authorisation","assistance":"https://www.astrazeneca-us.com/medicines/access-360","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended first-line (TA654), adjuvant (TA761), and after chemoradiation","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"},{"country":"CN","reimbursement":"NRDL listed since 2019 with major price 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(FLAURA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-12-18","type":"approval","region":"US","note":"Adjuvant EGFR-mutant NSCLC after resection (ADAURA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-02-16","type":"approval","region":"US","note":"First-line with chemotherapy (FLAURA2)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-09-25","type":"approval","region":"US","note":"Unresectable stage III after chemoradiation 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