Pemigatinib monotherapy (FIGHT-202) — 2L+ FGFR2-fusion cholangiocarcinoma
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-PEMIGATINIB |
|---|
| ID | REG-PEMIGATINIB-CHOLANGIO |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-30 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-BTC-2023 SRC-FIGHT-202 SRC-NCCN-HEPATOBILIARY |
Notes
FIGHT-202 phase 2 (Abou-Alfa Lancet Oncol 2020; SRC-FIGHT-202): pemigatinib 13.5 mg PO daily 14d on/7d off in advanced/metastatic cholangiocarcinoma post-≥1L systemic therapy. Cohort A (FGFR2 fusion / rearrangement, n=107): ORR 35.5% (38/107), DCR 82%, mPFS 6.9 mo, mOS 21.1 mo. FDA accelerated approval Apr 2020; converted to traditional approval after confirmatory data. Class FGFR-TKI toxicity: hyperphosphatemia (~60-90%, class effect from FGF23 axis), serous retinopathy / RPE detachment, nail / hair / mucosal toxicity. Resistance: gatekeeper V564F and molecular-brake mutations; futibatinib (covalent FGFR1-4 TKI, FOENIX-CCA2) retains activity against some pemigatinib- resistance variants. STUB pending Clinical Co-Lead sign-off; SRC-FIGHT-202 currently a stub source — full citation pending.
Used By
Indication
IND-CHOLANGIO-2L-FGFR2-FUSION-PEMIGATINIB- IND-CHOLANGIO-2L-FGFR2-FUSION-PEMIGATINIB
Regimen
REG-INFIGRATINIB-CHOLANGIO-2L- Infigratinib monotherapy (CBGJ398X2204) — 2L+ FGFR2-fusion cholangiocarcinoma (HISTORICAL)