FDA Approves Lirafugratinib for FGFR2-Positive Cholangiocarcinoma

The FDA has approved lirafugratinib (Lyrfigtu, Elevar), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced, or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. This approval is based on results from the REFOCUS study, which demonstrated improved objective response rate and duration of response.