Afatinib
Afatinib (Gilotrif) is an irreversible EGFR pill for lung cancer, notable for activity against uncommon EGFR mutations (G719X, L861Q, S768I).
LUX-Lung 3/6 (2013) versus chemotherapy in EGFR-mutant NSCLC; LUX-Lung 7 versus gefitinib. Approved for uncommon mutations in 2018. Also approved for squamous NSCLC after platinum (LUX-Lung 8). More rash, diarrhoea and paronychia than first-generation agents.
- 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.
- Assistance programmes
- Boehringer Ingelheim patient support
- 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
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA310 · SMC advice: afatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2013 | First-line metastatic NSCLC with EGFR exon 19 del or L858R |
| US | 2016 | Squamous NSCLC after platinum |
| US | 2018 | Uncommon EGFR mutations (S768I, L861Q, G719X) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Afatinib" OR ABSTRACT:"Afatinib" OR TITLE:"Gilotrif" OR ABSTRACT:"Gilotrif" OR TITLE:"Giotrif" OR ABSTRACT:"Giotrif") 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 Afatinib, not a curated reading list.
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