US FDA accepts futibatinib for Priority Review

Japan’s Taiho Oncology and Taiho Pharmaceutical - both owned by Otsuka Pharmaceutical (TYO: 4578) - announced today that the US Food and Drug Administration has accepted and granted priority review of the New Drug Application (NDA) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor, in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions.

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022. The NDA submitted in the USA is based on the data from the pivotal, Phase IIb FOENIX-CCA2 trial. Results from the trial were presented at the American Association for Cancer Research (AACR) Meeting 2021.1 Based on these data, the FDA granted Breakthrough Therapy designation (BTD) to futibatinib for the treatment of patients with previously treated locally advanced or metastatic CCA harboring FGFR2 gene rearrangements, including gene fusions in 2021.2

Would compete with Incyte’s Pemazyre