Pemigatinib

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

ID	`DRUG-PEMIGATINIB`
Type	Drug
Aliases	PemazyreПеміґатиніб
Status	reviewed 2026-04-30 \| pending_clinical_signoff
Diseases	`DIS-CHOLANGIOCARCINOMA`
Sources	`SRC-ESMO-BTC-2023` `SRC-FIGHT-202` `SRC-NCCN-HEPATOBILIARY`

Drug Facts

Class	Selective oral FGFR1/2/3 tyrosine kinase inhibitor
Mechanism	Reversible ATP-competitive selective inhibitor of FGFR1, FGFR2, and FGFR3 (lower activity vs FGFR4). Active against fusion-driven and amplification-driven FGFR2 alterations. Approved for FGFR2-fusion cholangiocarcinoma (FIGHT-202), relapsed/refractory MLN-eo with FGFR1 rearrangement (FIGHT-203), and other FGFR-driven indications.
Typical dosing	13.5 mg PO once daily, 14 days on / 7 days off (21-day cycle), until progression or unacceptable toxicity. Take with or without food. Monitor serum phosphate before each cycle; phosphate binders (sevelamer) + dietary phosphate restriction for hyperphosphatemia.
Ukraine registered	False
NSZU reimbursed	False
Ukraine last verified	2026-04-30

Warnings

Ocular toxicity: retinal pigment epithelial detachment (serous retinopathy) — baseline + serial ophtho exam; hold for symptomatic detachment

Notes

FIGHT-202 phase 2 (Abou-Alfa Lancet Oncol 2020): pemigatinib in advanced cholangiocarcinoma post-≥1L; FGFR2 fusion cohort A ORR 35.5% (n=107), DCR 82%, mPFS 6.9 mo, mOS 21.1 mo. FDA accelerated approval Apr 2020; converted to traditional approval after FIGHT-302 confirmatory. Class toxicity dominated by hyperphosphatemia and serous retinopathy. Resistance: gatekeeper V564F + molecular-brake mutations; futibatinib (covalent) retains activity against some pemigatinib-resistance variants. SRC-FIGHT-202 stub in KB — citation detail pending verification.

Used By

Drug

DRUG-INFIGRATINIB - Infigratinib

Regimens

REG-PEMIGATINIB-CHOLANGIO - Pemigatinib monotherapy (FIGHT-202) — 2L+ FGFR2-fusion cholangiocarcinoma