Posted by Michael Wonder on 01 Apr 2021
FDA grants breakthrough therapy designation for Taiho Oncology's futibatinib for treatment of advanced cholangiocarcinoma
1 April 2021 - Taiho Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for futibatinib (TAS-120), a covalently-binding FGFR inhibitor, for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions.
The decision by FDA to grant this designation is based on efficacy and safety results from the Phase 2 FOENIX-CCA2 study, which will be presented at the American Association for Cancer Research Annual Meeting 2021, taking place April 9-14, 2021.
