Agios Pharma’s Tibsovo nabs accelerated review in U.S. for type of MDS

The FDA designates Agios Pharmaceuticals’ (NASDAQ:AGIO) Tibsovo (ivosidenib) a Breakthrough Therapy for the treatment of adult patients with relapsed/refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Tibsovo is currently approved in the U.S. for certain IDH1-positive leukemia patients.

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https://seekingalpha.com/news/3526582-agios-pharmas-tibsovo-nabs-accelerated-review-in-u-s-for-type-of-mds