Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FGFR2::v status confers therapeutic sensitivity to Futibatinib in patients with Intrahepatic Cholangiocarcinoma.
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).
This statement is based on a regulatory approval from the Food and Drug Administration:
LYTGOBI is a kinase inhibitor 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).