Indications of Futibatinib

Futibatinib is indicated for the treatment of adult patients with previously treated, unresectable, locally  advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2)  gene fusions or other rearrangements.

This indication is approved under accelerated approval based on overall response rate and duration of response . Continued approval for this indication may be contingent upon verification and  description of clinical benefit in a confirmatory trial(s).

FDA，2022.09