The FDA approved lirafugratinib (Lyrfigtu) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements. The decision is based on the multicenter, open-label, single-group REFOCUS phase 1/2 trial. In REFOCUS, the FGFR2 inhibitor produced a 46% objective response rate and a median duration of response of 11.8 months, according to an independent review committee using RECIST v1.1 criteria. Regulators also highlighted class-relevant risks for ocular toxicity, hyperphosphatemia and soft-tissue mineralization, along with embryo-fetal toxicity warnings. The approval arrives with evidence presented earlier this year at an ASCO GI meeting, including a median progression-free survival of 11.3 months and a 12-month overall survival rate of 74.6%. That combination of activity and durability is likely to shape how FGFR2-rearranged bile-duct cancer is treated after prior chemotherapy. Overall, the label further expands the portfolio of FGFR-directed options in a rare cancer segment where targeted therapies increasingly dictate survival outcomes after progression.