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Afatinib (Gilotrif) is a second-generation pill that binds EGFR, HER2 and HER4 irreversibly, approved in 2013 for EGFR-mutant lung cancer. Its lasting value is activity against the uncommon EGFR mutations G719X, L861Q and S768I, approved in 2018, because osimertinib has displaced it for common mutations and its wild-type EGFR binding causes more rash and diarrhoea.
Afatinib is a second-generation, irreversible pan-ErbB tyrosine kinase inhibitor that covalently binds EGFR, HER2 and HER4. LUX-Lung 3 and LUX-Lung 6 (2013) showed superiority over chemotherapy in EGFR-mutant NSCLC, leading to US approval in 2013 for first-line exon 19 deletion or L858R disease, and LUX-Lung 7 compared it with gefitinib. Its distinctive value is activity against uncommon EGFR mutations, G719X, L861Q and S768I, for which it was approved in 2018, and LUX-Lung 8 also supported approval in 2016 for squamous NSCLC after platinum. Because it also hits wild-type EGFR irreversibly, it causes more rash, diarrhoea and paronychia than first-generation agents, and dose reduction is common. Osimertinib has displaced it for common mutations. For a newcomer, afatinib is the EGFR pill to remember for the rarer mutations.
1.Afatinib slips into a pocket on EGFR.
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.
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 TA310 · SMC advice: afatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| 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) |
| EU | 2013 | EU brand Giotrif |
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Together with the German MASTER report, this paper is why guidelines recommend comprehensive profiling with fusion detection in KRAS wild-type pancreatic cancer.
KRAS wild-type status should trigger fusion testing, ideally by RNA sequencing, because NRG1 fusions can be targeted by HER-family inhibitors and now by zenocutuzumab.
Query 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.
Shares EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study, HER4 (ERBB4), EGFR L858R, EGFR exon 19 deletion.
Shares LUX-Lung 3, EGFR L858R, EGFR exon 19 deletion, EGFR-mutated non-small-cell lung cancer.
Shares EGFR L858R, EGFR exon 19 deletion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR.
Shares EGFR L858R, EGFR exon 19 deletion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR.
Shares HER2-mutant non-small-cell lung cancer, EGFR-mutated non-small-cell lung cancer, EGFR, HER2.
Shares HER2-mutant non-small-cell lung cancer, EGFR-mutated non-small-cell lung cancer, EGFR, HER2.
Shares EGFR L858R, EGFR exon 19 deletion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR-mutated non-small-cell lung cancer.
Shares HER4 (ERBB4), HER2-mutant non-small-cell lung cancer, EGFR, HER2.