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Futibatinib

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

IDDRUG-FUTIBATINIB
TypeMédicament
Alias
LytgobiФутибатиніб
Étatreviewed 2026-04-29 | pending_clinical_signoff
MaladiesDIS-CHOLANGIOCARCINOMA
SourcesSRC-ESMO-BTC-2023 SRC-FOENIX-CCA2 SRC-NCCN-HEPATOBILIARY

Faits sur les drogues

CatégorieInhibiteur sélectif de la tyrosine kinase (covalent) FGFR1/2/3//4
MécanismeOral, highly selective irreversible covalent inhibitor of FGFR1, FGFR2, FGFR3, and FGFR4. Forms a covalent bond with a conserved cysteine in the FGFR P-loop, conferring sustained target inhibition with reduced off-target activity vs ATP-competitive reversible FGFR TKIs. Designed to retain potency against gatekeeper (e.g. FGFR2 V564F) and molecular-brake resistance mutations that drive acquired resistance to reversible FGFR inhibitors (pemigatinib, infigratinib). Pivotal FOENIX-CCA2 Phase II (n=103, FGFR2 fusion / rearrangement cholangiocarcinoma post ≥1 prior line including gem-cis) showed ORR 41.7%, mDOR 9.7 months, mPFS 9.0 months, mOS 21.7 months → FDA accelerated approval Sep 2022.
Dose typique20 mg PO once daily continuously, until disease progression or unacceptable toxicity. Take with or without food at the same time each day. Hold + reduce for grade ≥3 hyperphosphatemia despite phosphate binders + diet (target serum phosphate <7.0 mg/dL); hold for any retinal pigment epithelial detachment (RPED) until resolution. Dose reductions: 16 mg → 12 mg → permanent discontinuation.
Ukraine enregistréeFaux
NSZU rembourséFaux
Ukraine vérifiée pour la dernière fois2026-04-29

Notes

Futibatinib is the second FGFR-targeted therapy approved for FGFR2 fusion / rearrangement cholangiocarcinoma (after pemigatinib). Its irreversible covalent mechanism is the key differentiator: retains activity against several gatekeeper (V564F) + molecular-brake resistance mutations that drive acquired resistance to pemigatinib / infigratinib (Goyal NEJM 2019). FOENIX-CCA2 (Goyal NEJM 2023) is the pivotal Phase II — 103 patients, FGFR2 fusion / rearrangement iCCA post ≥1 prior line including gem-cis, ORR 41.7%, DCR 82.5%, mDOR 9.7 mo, mPFS 9.0 mo, mOS 21.7 mo, all CTCAE-v5 hyperphosphatemia grade ≥3 manageable with binders + diet, RPED rate ~9%. NCCN-Hepatobiliary + ESMO-BTC-2023 list both pemigatinib and futibatinib as preferred 2L+ options for FGFR2-altered iCCA. FOENIX-CCA3 (1L vs gem+cis) is the post-marketing confirmatory required for accelerated → traditional approval conversion. Class toxicity dominated by hyperphosphatemia (target <7.0 mg/dL) and serous retinopathy (monthly ophtho + OCT for first 4 mo, then per protocol). Missing source IDs to flag: SRC-FDA-LYTGOBI not yet authored; FOENIX-CCA3 trial source pending.

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