Otsuka Gains Accelerated Approval for Bile Duct Cancer

October 4, 2022

Otsuka subsidiary Taiho Oncology has gained an accelerated approval from the FDA for its Lytgobi (futibatinib) tablets for treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) — cancer that occurs in parts of the bile ducts that are inside the liver.

The approval is specifically for patients whose cancers harbor fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

The accelerated approval was based on a primary analysis of a phase 2 clinical trial that met its primary endpoint with an objective response rate of 42 percent. The median duration of response was 9.7 months, with 72 percent of responses lasting at least six months.

Continued approval for the drug will depend on the verification of its clinical benefit in a confirmatory trial or trials.

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