Infigratinib monotherapy (CBGJ398X2204) — 2L+ FGFR2-fusion cholangiocarcinoma (HISTORICAL)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-INFIGRATINIB |
|---|
| ID | REG-INFIGRATINIB-CHOLANGIO-2L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| 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 WITHDRAWN voluntarily Aug-Sep 2022 (Helsinn divested oncology portfolio; QED Therapeutics ceased commercial operations) — NOT a safety withdrawal.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.
Used By
Indication
IND-CHOLANGIO-2L-INFIGRATINIB- IND-CHOLANGIO-2L-INFIGRATINIB