Posted by Michael Wonder on 07 Mar 2022
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with previously untreated IDH1 mutated acute myeloid leukaemia
7 March 2022 - sNDA based on data from the global, Phase 3, AGILE trial evaluating Tibsovo in combination with azacitidine in previously untreated IDH1 mutated acute myeloid leukaemia.
Servier today announced that the U.S. FDA has accepted the company’s supplemental new drug application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukaemia.
