FDA Approves Lirafugratinib for FGFR2+ Metastatic Cholangiocarcinoma

The FDA has approved lirafugratinib (Lyrfigtu, Elevar), a kinase inhibitor, for 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 an improved objective response rate and duration of response. Warnings for lirafugratinib include ocular toxicity, hyperphosphatemia, soft tissue mineralization, and embryo-fetal toxicity.