FDA 'Breakthrough' status for Taiho's futibatinib

2 April 2021
taiho-big

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology