Posted by Michael Wonder on 25 May 2022
Servier announces FDA approval of Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1 mutated acute myeloid leukaemia
25 May 2022 - FDA approval based on data from the global, Phase 3 AGILE trial that demonstrated a statistically significant improvement in event-free survival and overall survival
Servier today announced that the U.S. FDA approved Tibsovo (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1 mutated acute myeloid leukaemia in adults 75 years or older, or who have co-morbidities that preclude use of intensive induction chemotherapy.
