26 March 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia with an IDH1 mutation in adult patients who are ≥75 years old or who have co-morbidities that preclude use of intensive induction chemotherapy.

Results from the Phase 1/2 study of ivosidenib in combination with azacitidine were last presented at the 17th International Symposium on Acute Leukemias in Munich.

Ivosidenib is not approved in any country for the treatment of patients with newly diagnosed acute myeloid leukaemia or approved in combination with azacitidine.

Read Agios Pharmaceuticals press release