FDA Grants Approval to Lirafugratinib for Advanced Cholangiocarcinoma with FGFR2 Alteration

The FDA has approved lirafugratinib, an oral FGFR2 inhibitor, for previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusion or rearrangement, based on positive phase 1/2 ReFocus trial results demonstrating a 46.5% response rate and manageable safety profile.

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