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SEP 27 2026
UPCOMING · 58 DAYS TO PDUFA

Elevar Therapeutics lirafugratinib

for cholangiocarcinoma

NDA · Priority Review

Accepted MAR 30 2026.

About

Cholangiocarcinoma is a cancer that forms in the bile ducts and can cause abdominal pain, severe itching, and jaundice. Lirafugratinib is a drug designed to target and block the activity of the FGFR2 protein in tumors. This approach could potentially slow the growth of bile duct cancers driven by specific FGFR2 genetic changes.

Pivotal trial

ReFocus202 Phase 2 recruiting NCT07359820

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: * Take lirafugratinib regularly as instructed by their study doctor

Source: ClinicalTrials.gov