Posted by Michael Wonder on 30 Mar 2022
U.S. FDA accepts for priority review Taiho Oncology's new drug application for futibatinib for cholangiocarcinoma
30 March 2022 - Taiho Oncology and Taiho Pharmaceutical announced today that the U.S. FDA has accepted for priority review the new drug application for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harbouring FGFR2 gene rearrangements, including gene fusions.
Futibatinib is an investigational, oral, potent, selective and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4.
The FDA provided an anticipated Prescription Drug User Fee Act action date of 30 September 2022.
