FDA approves Taiho's bile cancer drug Lytgobi

The US Food and Drug Administration (FDA) has approved Lytgobi (futibatinib) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

The treatment for this rare form of bile cancer was developed by Taiho Oncology and Taiho Pharmaceuticals, both subsidiaries of Japanese drugmaker Otsuka Holdings (TYO: 4578).

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).