Posted by Michael Wonder on 18 Dec 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation
16 December 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with a susceptible IDH1 mutation as detected by an FDA-approved test.
Myelodysplastic syndrome is a group of bone marrow disorders that can cause severe complications, such as infections and uncontrolled bleeding, and can lead to the development of acute myelogenous leukaemia.
