Infigratinib en monoterapia (CBGJ398X2204) — 2L+ FGFR2-fusion colangiocarcinoma (HISTORICO)
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
Registro de base de conocimiento para la auditoría. Contenido clínico provisional: esto no es una prescripción. Un oncólogo debe verificar fuentes originales, aplicabilidad y estado de revisión.
Fuente YAML: registro completo
| Componentes | DRUG-INFIGRATINIB |
|---|
| ID | REG-INFIGRATINIB-CHOLANGIO-2L |
|---|---|
| Tipo | Esquema terapéutico |
| Situación | reviewed 2026-04-29 | pending_clinical_signoff |
| Enfermedades | Ninguna declarada |
| Fuentes | SRC-ESMO-BTC-2023 SRC-NCCN-HEPATOBILIARY |
Notas
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 WITHDRAWN voluntarily Aug-Sep 2022 (Helsinn divested oncology portfolio; QED Therapeutics ceased commercial operations) — NOT a safety withdrawal.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.
Utilizado por
Indicación
IND-CHOLANGIO-2L-INFIGRATINIB- IND-CHOLANGIO-2L-INFIGRATINIB