FDA Approves Lyrfigtu for FGFR2+ Advanced Cholangiocarcinoma

The FDA has approved Lyrfigtu (lirafugratinib), an oral FGFR2 inhibitor, for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements, following positive phase 1/2 trial results showing a 46.5% objective response rate.

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