News Oct22

Taiho Pharmaceutical Co., Ltd. (“Taiho Pharmaceutical”) and its U.S. subsidiary Taiho Oncology, Inc. (“Taiho Oncology”) announced today that the U.S. Food and Drug Administration (FDA) 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 U.S. is based on the data from the pivotal, Phase 2b 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 “This is a very important step towards our goal to deliver futibatinib to patients awaiting potential new treatment options,” says Teruhiro Utsugi, Senior Managing Director at Taiho Pharmaceutical. “The Taiho group, working as one, will continue to do its utmost to deliver this agent to those in need.” “Given the lack of accepted standard chemotherapy following the failure of firstline treatment, 3 futibatinib could represent a significant opportunity for a targeted therapy in subset of patients with CCA, which has driven our pursuit with this investigational compound,” said Volker Wacheck, Vice President, Clinical Development, Taiho Oncology. “We look forward to working with the FDA as they consider the application for futibatinib under priority review.” Through research and development of innovative treatments, the Taiho group aims to contribute to patients and healthcare professionals around the world

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