Infigratinib en monothérapie (CBGJ398X2204) — cholangiocarcinome 2L+-fusion FGFR2 (HISTORIQUE)
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.
Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.
| Composantes | DRUG-INFIGRATINIB |
|---|
| ID | REG-INFIGRATINIB-CHOLANGIO-2L |
|---|---|
| Type | Protocole thérapeutique |
| État | reviewed 2026-04-29 | pending_clinical_signoff |
| Maladies | Aucune déclaration |
| Sources | SRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY |
Notes
CBGJ398X2204 (Javle JCO 2018, Javle Lancet Gastroenterol Hepatol 2021): infigratinib 125 mg PO daily 21d on / 7d off, advanced / metastatic cholangiocarcinoma with FGFR2 fusion / rearrangement post-≥1L gemcitabine-based therapy (n=108). ORR 23.1% (25/108), DCR 84.3%, mDoR 5.0 mo, mPFS 7.3 mo, mOS 12.2 mo. FDA accelerated approval May 2021. WITHDRAWN voluntarily Aug-Sep 2022 (Helsinn divested oncology portfolio; QED Therapeutics ceased commercial operations) — NOT a safety withdrawal. Subsequent FGFR-TKIs (pemigatinib FIGHT-202, futibatinib FOENIX-CCA2) replaced infigratinib in NCCN / ESMO guidance. Class toxicity profile identical to other reversible FGFR1-3 TKIs: hyperphosphatemia (~76%), retinal detachment, alopecia, nail toxicity. STUB pending Clinical Co-Lead sign-off; flagged HISTORICAL — render layer must not surface as an active recommendation. Bibliographic record SRC-CBGJ398X2204 is available as historical evidence; source-to-claim mapping requires dual clinical sign-off.
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Indication
IND-CHOLANGIO-2L-INFIGRATINIB- IND-CHOLANGIO-2L-INFIGRATINIB