Onco Wiki - Drogas

Futibatinib

Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.

IDDRUG-FUTIBATINIB
TipoFármaco
Aliaces
- ¿Qué?Футибатиніб
Situaciónreviewed 2026-04-29 | pending_clinical_signoff
EnfermedadesDIS-CHOLANGIOCARCINOMA
FuentesSRC-ESMO-BTC-2023 SRC-FOENIX-CCA2 SRC-NCCN-HEPATOBILIARY

Datos sobre drogas

ClaseInhibidor selectivo de tirosina quinasa (covalente) FGFR1/2/3//4
MecanismoOral, 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.
Dosificación típica20 mg PO una vez al día, continuamente, hasta la progresión de la enfermedad o toxicidad inaceptable. Tomar con o sin alimentos a la misma hora cada día. Mantenga + reducir para el grado ≥3 hiperfosfatemia a pesar de los aglutinantes de fosfato + dieta (fosfato sérico objetivo < 7,0 mg/dL); mantener para cualquier desprendimiento epitelial de pigmento retinario (DEP) hasta la resolución. Reducciones de dosis: 16 mg → 12 mg → suspensión permanente.
Ucrania registradaFalso
NSZU reembolsadoFalso
Ucrania verificada por última vez2026-04-29

Notas

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.

Utilizado por

Fármaco

Esquema terapéutico