OnCo
drugsProductNot mapped hereapproved

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.

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Afatinib
PubChem
Modality
Small-molecule pan-ErbB TKI (second generation, irreversible)
Mechanism
Covalent inhibitor of EGFR, HER2 and HER4 kinases.
Brand / code
Gilotrif / Giotrif
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

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.

NICE recommendedNICE TA310 · 2014SMC: accepted
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.

Regulatory

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Approvals

RegionYearIndication
US2013First-line metastatic NSCLC with EGFR exon 19 del or L858R
US2016Squamous NSCLC after platinum
US2018Uncommon EGFR mutations (S768I, L861Q, G719X)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
140 studies7 recruiting90 Phase 212 Phase 3
Search “Afatinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Afatinib
intervention: Afatinib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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