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SEP 27 2026
UPCOMING · 116 DAYS TO PDUFA

Elevar Therapeutics lirafugratinib

for cholangiocarcinoma

NDA · Priority Review

Accepted MAR 30 2026.

About

Cholangiocarcinoma is a bile duct cancer that causes abdominal pain, jaundice, and severe itching as tumors block bile flow. Lirafugratinib blocks FGFR2, a protein that drives tumor growth when its genetic code gets scrambled into abnormal fusion patterns. By targeting these faulty FGFR2 signals, the drug may slow cancer progression in patients whose tumors rely on this specific molecular malfunction.

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