FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma
PRINCETON, N.J. and TOKYO, April 1, 2021 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) 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. Futibatinib is an investigational therapy and has not been approved by any regulatory authority for use in patients.
"Patients living with locally advanced and metastatic cholangiocarcinoma, or bile duct cancer, currently have a poor prognosis,1,2 particularly since there is no standard treatment after the failure of first-line chemotherapy3," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We are pleased that the FDA has recognized the potential benefit of futibatinib in previously treated CCA patients. We look forward to continued dialogue with FDA and other Health Authorities as we work toward global availability of futibatinib for cholangiocarcinoma patients."
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 (AACR) Annual Meeting 2021, taking place April 9-14, 2021.
"We are very pleased with the designation of futibatinib as a breakthrough therapy by the FDA," said Teruhiro Utsugi, Ph.D., Senior Managing Director at Taiho. "We will continue to advance our research and development efforts to deliver futibatinib, discovered in our research center, as one of the agents which may benefit cholangiocarcinoma patients around the world awaiting for new treatment options."
The FDA states that Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for BTD require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
In May 2018, the FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.
The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.2
About Futibatinib (TAS-120)
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About Taiho Oncology, Inc. (U.S.)
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1 American Cancer Society. Survival Rates for Bile Duct Cancer. https://www.cancer.org/cancer/bile-duct-cancer/detection-diagnosis-staging/survival-by-stage.html. Accessed March 2021.
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SOURCE Taiho Oncology, Inc.