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Osimertinib (Tagrisso) is the standard pill for EGFR-mutant lung cancer, now also given after surgery and with chemotherapy or after chemoradiation.
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.
Irreversible third-generation EGFR TKI sparing wild-type EGFR; active against T790M; CNS penetrant. Connects to EGFR.
1.Oral drug is absorbed and reaches the tumour
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. EGFR mutation by an approved test; adjuvant and unresectable stage III uses have their own criteria.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA654 · NHS England Cancer Drugs Fund list · SMC advice: osimertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Would move the TROP2 ADC into the first-line EGFR-mutant setting on top of the standard TKI. Timing is a registry-based estimate. Source
Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy
Accelerated approval, EGFR T790M NSCLC after TKI source
Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy
Full approval (AURA3) source
First-line EGFR-mutant NSCLC (FLAURA) source
Adjuvant EGFR-mutant NSCLC after resection (ADAURA) source
First-line with chemotherapy (FLAURA2) source
Unresectable stage III after chemoradiation (LAURA) source
| Region | Year | Indication |
|---|---|---|
| US | 2015 | EGFR T790M NSCLC |
| US | 2018 | First-line EGFR-mutant NSCLC |
| US | 2020 | Adjuvant EGFR-mutant NSCLC |
| England (NICE) | 2020 | Untreated locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer · TA654, published 14 October 2020, recommends osimertinib within its marketing authorisation subject to the commercial arrangement. |
| England (NICE) | 2020 | EGFR T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer after a first-line EGFR inhibitor · TA653, published 14 October 2020, subject to the commercial arrangement. |
| England (NICE) | 2025 | Adjuvant treatment of stage IB to IIIA EGFR exon 19 deletion or L858R non-small-cell lung cancer after complete resection · 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. |
| England (NICE) | 2025 | Untreated advanced EGFR mutation-positive non-small-cell lung cancer, with pemetrexed and platinum-based chemotherapy · TA1060, published 8 May 2025, subject to the commercial arrangement (FLAURA2). |
| England (NICE) | 2026 | Unresectable stage III EGFR mutation-positive non-small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy · TA1156, published 21 May 2026 (LAURA); must be funded in England within 90 days of publication. |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea FLAURA | 58% | 2.2% |
| Rash FLAURA | 58% | 1.1% |
| Dry skin FLAURA | 36% | 0.4% |
| Nail toxicity FLAURA | 35% | 0.4% |
| Stomatitis FLAURA | 32% | 0.7% |
| Fatigue FLAURA | 21% | 1.4% |
| Decreased appetite FLAURA | 20% | 2.5% |
| Interstitial lung disease 0.4% fatal; higher after chemoradiation | 4% | - |
| Cardiomyopathy FLAURA | 3.8% | - |
| QTc >500 ms FLAURA | 1.1% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | astrazeneca-us.com/medicines/access-360 |
| United Kingdom | NICE: recommended first-line (TA654), adjuvant (TA761), and after chemoradiation | not disclosed | - |
| China | NRDL listed since 2019 with major price cut | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The survival benefit first reported in 2023 has held five years after the last dose of adjuvant osimertinib, which answers the worry that a three-year course only delays relapse. Patients with an exon 19 deletion gained most; the L858R estimate crosses one and is less certain. Nothing here changes the recommendation, which already rests on the 2023 analysis, but it tightens the case for testing every resected non-squamous tumour for EGFR mutations.
For a patient weighing the FLAURA2 regimen against osimertinib alone, the extra toxicity is front-loaded: the hardest months are the four induction cycles, and once pemetrexed stops the profile returns to that of osimertinib by itself. Kidney function deserves watching during pemetrexed maintenance.
Patients newly diagnosed with EGFR-mutated advanced lung cancer now have a first-line option that improves survival over osimertinib, particularly if they have high-risk features. The trade-off is intravenous (now subcutaneous) infusions and considerably more skin, nail and clotting toxicity, so osimertinib alone remains reasonable for those who prioritise convenience and tolerability. Both this regimen and osimertinib plus chemotherapy (FLAURA2) are approved; there is no direct comparison.
Stage III lung cancer is now treated by genotype as well as by stage: an EGFR mutation moves a patient from durvalumab consolidation to osimertinib consolidation. It is also the strongest hazard ratio in the lung cancer literature, which is a reason to read the overall survival data carefully when they arrive.
Adding chemotherapy to osimertinib delays progression. Whether it extends life, and whether the same benefit could be had by giving the chemotherapy later to the patients who need it, is what the overall survival analysis and the registry watch on this roadmap are for.
Every resected non-squamous lung cancer should be tested for EGFR mutations, because patients who carry one live longer if they take osimertinib for three years after surgery. The trial does not tell us whether adjuvant chemotherapy can be omitted, nor what happens on relapse after osimertinib, and the three-year duration was chosen empirically.
It changed how resistance is investigated: the first question at progression on osimertinib is whether T790M is still there, because losing it means the tumour is no longer EGFR-driven in the growing compartment and another EGFR inhibitor will not help.
Anyone diagnosed with advanced lung cancer should have EGFR testing before treatment, because osimertinib as the first drug gives the longest disease control, protects the brain, and is well tolerated. Chemotherapy is not the first step for these patients. The remaining questions are whether to intensify upfront (adding chemotherapy or amivantamab) and how to treat resistance when it develops.
Query for this drug: (TITLE:"Osimertinib" OR ABSTRACT:"Osimertinib" OR TITLE:"Tagrisso" OR ABSTRACT:"Tagrisso") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Osimertinib, not a curated reading list.
Shares EGFR TKI → ADC on progression, A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth, Dae Ho Lee, Amivantamab + lazertinib (first-line EGFR NSCLC).
Shares Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone, Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD), A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RE, EGFR exon 19 deletion & L858R.
Shares Eyebrow and eyelash loss (madarosis), A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RE, cobas EGFR Mutation Test v2, EGFR exon 19 deletion & L858R.
Shares Graded Prognostic Assessment (GPA) for brain metastases, Myung-Ju Ahn, Brain metastases included by default in every solid-tumour trial, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC.
Shares Myung-Ju Ahn, Enriqueta Felip, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Shanghai Chest Hospital.
Shares Dae Ho Lee, Amivantamab + lazertinib (first-line EGFR NSCLC), EGFR exon 19 deletion & L858R, EGFR L858R.
Shares Pause a failed drug so the tumour becomes sensitive to it again, Forecast the next resistance mutation like the weather, AURA3, Kill drug-tolerant persisters through ferroptosis.
Shares Dae Ho Lee, Amivantamab + lazertinib (first-line EGFR NSCLC), Add a drug when the blood test turns, without stopping the one that works, Shanghai Chest Hospital.