Agios receives FDA Breakthrough Designation for Tibsovo

Agios Pharmaceuticals announced that the FDA has granted Breakthrough Therapy designation for Tibsovo in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia with an IDH1 mutation in adult patients who are greater than or equal to75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
https://thefly.com/landingPageNews.php?id=2884581