Therapeutic Response

FGFR2::v status confers therapeutic sensitivity to Futibatinib in patients with Intrahepatic Cholangiocarcinoma.

Statements

Source and description

Lytgobi (futibatinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to futibatinib 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. Futibatinib's package insert states that this indication is approved under accelerated approval based on overall response rate and duration of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).