FDA 'Breakthrough' status for Taiho's futibatinib

Japan’s Taiho Oncology and Taiho Pharmaceutical - both owned by Otsuka Pharmaceutical (TYO: 4578) – have announced that the US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor.

Futibatinib is intended 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.

In April 2020, US biotech Incyte (Nasdaq: INCY) won US approval for Pemazyre (pemigatinib), as a second-line option for certain people with locally-advanced or metastatic bile duct cancer, also known as cholangiocarcinoma, making it the first and only Food and Drug Administration-approved treatment for this indication. Incyte added European approval for its drug earlier this month.