Innovative FGFR inhibitor for the treatment of cholangiocarcinoma was granted priority review by the FDA

Today, Japan’s Taiho Pharmaceutical and its subsidiary Taiho Oncology announced that the U.

Cholangiocarcinoma includes intrahepatic and extrahepatic cholangiocarcinoma, and it usually occurs in the elderly

Futibatinib inhibits FGFR-mediated signaling by irreversibly covalently binding to the ATP-binding "pocket" of FGFR1-4, thereby reducing the proliferation of tumor cells harboring FGFR1-4 genetic variants

▲Schematic diagram of the mechanism of action of Futibatinib (Image source: Reference [2])

The filing is based on data from a pivotal Phase 2b clinical trial in which 103 patients received futibatinib

"This is an important step toward our goal of bringing futibatinib to patients in need of new treatment options,

References:

[1] US Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology's New Drug Application for Futibatinib for Cholangiocarcinoma.

[2] Sootome et al.