New Drug Application of FGFR inhibitor futibatinib filed with MHLW (Japan) for biliary tract cancer.- Taiho
Taiho Pharmaceutical Co., Ltd. announced that it has submitted to the Japanese Ministry of Health, Labour and Welfare a new drug application for futibatinib (TAS-120), a FGFR inhibitor as a treatment for previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions.
The NDA submitted is based on the data from the Phase II FOENIX-CCA2 trial. FOENIX-CCA2 trial was a Phase II trial in 103 patients with locally advanced or metastatic unresectable intrahepatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. In the trial, patients who had received one or more prior lines of systemic therapy received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The trial’s primary endpoint was objective response rate (ORR) : Percentage of patients with objective evidence of response to anticancer treatment and other treatments. Furthermore, a companion diagnostic device to detect FGFR2 gene rearrangements including gene fusions is being jointly developed in Japan with Sysmex Corporation.
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