FDA Approves Lyrfigtu for FGFR2-Rearranged Cholangiocarcinoma

The FDA approved Lyrfigtu (lirafugratinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, based on the REFOCUS phase 2 trial. This approval introduces a new option alongside pemigatinib, an existing treatment with six years of market presence.

This Wire brief sits within Fusion42's coverage of Biotech, and 10 sources have reported it between 16 Sep 2026 and 5 Oct 2026.