Futibatinib monotherapy (FOENIX-CCA2) — 2L+ FGFR2-fusion cholangiocarcinoma

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Source YAML: complete record

Components	`DRUG-FUTIBATINIB`

ID	`REG-FUTIBATINIB-CHOLANGIO-2L`
Type	Regimen
Status	reviewed 2026-04-29 \| pending_clinical_signoff
Diseases	None declared
Sources	`SRC-ESMO-BTC-2023` `SRC-FOENIX-CCA2` `SRC-NCCN-HEPATOBILIARY`

Notes

FOENIX-CCA2 phase 2 (Goyal NEJM 2023): futibatinib 20 mg PO daily, continuous, in advanced/metastatic intrahepatic cholangiocarcinoma with FGFR2 fusion / rearrangement, post-≥1L systemic therapy (n=103). ORR 41.7% (43/103), DCR 82.5%, mDoR 9.7 mo, mPFS 9.0 mo, mOS 21.7 mo. FDA accelerated approval Sep 2022; EMA Jun 2023. Futibatinib is a covalent (irreversible) pan-FGFR1-4 TKI; differs mechanistically from reversible FGFR-TKIs (pemigatinib, infigratinib) and retains activity against some gatekeeper / molecular-brake resistance mutations after pemigatinib failure (sequencing data ASCO 2023). Class toxicity: hyperphosphatemia (~85%), nail / hair toxicity, dry mouth, alopecia, retinal detachment (less frequent than pemigatinib in cross-trial). STUB pending Clinical Co-Lead sign-off.

Used By

Indication

IND-CHOLANGIO-2L-FUTIBATINIB - IND-CHOLANGIO-2L-FUTIBATINIB

Regimen

REG-INFIGRATINIB-CHOLANGIO-2L - Infigratinib monotherapy (CBGJ398X2204) — 2L+ FGFR2-fusion cholangiocarcinoma (HISTORICAL)