Osimertinib
Osimertinib (Tagrisso) is the standard pill for EGFR-mutant lung cancer, now also given after surgery and with chemotherapy or after chemoradiation.
FLAURA (first-line OS benefit), ADAURA (adjuvant, OS HR 0.49), FLAURA2 (with chemotherapy, OS benefit 2025), LAURA (after chemoradiation in stage III). Challenged by amivantamab-lazertinib (MARIPOSA).
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 80 mg once daily with or without food; adjuvant up to 3 years
- Dose 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: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- AstraZeneca Access 360
- AZ&Me Prescription Savings
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- Untreated EGFR mutation-positive NSCLC (FLAURA)
- Notes
- Moved to routine commissioning. T790M after a first-generation TKI: TA416 (2016, CDF then routine). Adjuvant stage IB-IIIA (ADAURA): TA761 (2022). With chemotherapy (FLAURA2) and after chemoradiation (LAURA) appraised later.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
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.
- 13 Nov 2015ApprovalUS
Accelerated approval, EGFR T790M NSCLC after TKI source
- 30 Mar 2017ApprovalUS
Full approval (AURA3) source
- 18 Apr 2018ApprovalUS
First-line EGFR-mutant NSCLC (FLAURA) source
- 18 Dec 2020ApprovalUS
Adjuvant EGFR-mutant NSCLC after resection (ADAURA) source
- 16 Feb 2024ApprovalUS
First-line with chemotherapy (FLAURA2) source
- 25 Sept 2024ApprovalUS
Unresectable stage III after chemoradiation (LAURA) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | EGFR T790M NSCLC |
| US | 2018 | First-line EGFR-mutant NSCLC |
| US | 2020 | Adjuvant EGFR-mutant NSCLC |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
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.
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.
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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductAmivantamab
Shares EGFR TKI → ADC on progression, Dae Ho Lee, EGFR exon 19 deletion & L858R, Amivantamab + lazertinib (first-line EGFR NSCLC).
- TargetALK
Shares On-target resistance mutations (gatekeeper, solvent-front, compound), Myung-Ju Ahn, Enriqueta Felip, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC.
- ProductLorlatinib
Shares Myung-Ju Ahn, Brain metastases included by default in every solid-tumour trial, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Prevention trials aimed only at brain metastasis.
- TargetMET
Shares Dae Ho Lee, Amivantamab + lazertinib (first-line EGFR NSCLC), Add a drug when the blood test turns, without stopping the one that works, Add the second drug on day one when the escape route is predictable.
- TrialMARIPOSA
Shares Dae Ho Lee, Amivantamab + lazertinib (first-line EGFR NSCLC), Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer.
- TermDrug resistance (primary and acquired)
Shares Forecast the next resistance mutation like the weather, Pause a failed drug so the tumour becomes sensitive to it again, On-target resistance mutations (gatekeeper, solvent-front, compound), Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models.
- TermOncogene addiction
Shares West Japan Oncology Group, ADAURA: three years of osimertinib after surgery for EGFR-mutated lung cancer, Guangdong Provincial People's Hospital, Tyrosine kinase inhibitor (TKI).
- ProductLazertinib
Shares Dae Ho Lee, EGFR exon 19 deletion & L858R, Amivantamab + lazertinib (first-line EGFR NSCLC), Drug-tolerant persister cells.