FGFR2 fusion in intrahepatic cholangiocarcinoma (~10-15%): pemigatinib (FIGHT-202, Abou-A...

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ID	`BMA-FGFR2-FUSION-CHOLANGIO`
Tipo	Relevância terapêutica
Estado	reviewed 2026-04-27 \| pending_clinical_signoff \| actionability review required
Doenças	`DIS-CHOLANGIOCARCINOMA`
Fontes	`SRC-CIVIC` `SRC-FDA-CDS-2026`

Fatos de ação

Biomarcador	`BIO-FGFR2`
Variante	fusão/rearranjo (BICC1-FGFR2 mais frequente; ~10-15% intra-hepático colangio)
Doença	`DIS-CHOLANGIOCARCINOMA`
Nível ESCAT	IA
Combinações recomendadas	pemigatinib monotherapy (2L+ post-gemcitabine/cisplatin), futibatinib monotherapy (2L+; preferred after pemigatinib resistance)
Resumo das provas	FGFR2 fusion in intrahepatic cholangiocarcinoma (~10-15%): pemigatinib (FIGHT-202, Abou-Alfa Lancet Oncol 2020 — ORR 36%, mDOR 9.1 mo) and futibatinib (FOENIX-CCA2, Goyal NEJM 2023 — ORR 42%, mPFS 9.0 mo) are FDA-approved for previously-treated FGFR2-fusion cholangio. Futibatinib is irreversible and has activity against pemigatinib-resistance gatekeeper mutations.

Notas

ESCAT IA. OncoKB Level 1. 1L remains gemcitabine + cisplatin ± durvalumab (TOPAZ-1). FGFR2-fusion testing recommended at diagnosis by NCCN to plan 2L. Detection: RNA-NGS preferred (intronic breakpoints commonly missed by DNA panels). Resistance: gatekeeper V564F, molecular brake L617M, kinase-domain N549K — futibatinib retains activity vs many of these. Source-gap: SRC-NCCN-HEPATOBILIARY / SRC-FIGHT-202 / SRC-FOENIX-CCA2 not yet ingested.

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