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Innovative FGFR inhibitor futibatinib received FDA breakthrough therapy designation

 Last Update: 2021-04-14
 Source: Internet
 Author: User

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Today, Taiho Pharmaceutical and its subsidiary Taiho Oncology announced that the US FDA has granted the irreversible FGFR oral inhibitor futibatinib (TAS-120) breakthrough therapy designation for the treatment of locally advanced or metastatic cholangiocarcinoma (cholangiocarcinoma).

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

Futibatinib is an oral, selective, and irreversible FGFR1-4 small molecule inhibitor.

The grant of this breakthrough therapy designation is based on the results of a Phase 2 clinical trial called FOENIX-CCA2.

Patients in different subgroups all experienced objective remission.

In China, many biopharmaceutical companies, including Nuocheng Jianhua, Cinda Bio, CStone Pharmaceuticals, and Zai Lab, are also developing different types of FGFR inhibitors for the treatment of advanced cholangiocarcinoma, hepatocellular carcinoma, and gastric cancer.

Reference materials:

[1] FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma.

[2] FUTABATINIB FOR PATIENTS WITH INTRAHEPATIC CHOLANGIOCARCINOMA AND FGFR2 FUSIONS OR REARRANGEMENTS.

[3] Sootome et al.

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