The FDA approved the combination of ivosidenib (Tibsovo, Servier) plus azacitidine for adults aged 75 years and older who are newly diagnosed with acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
The combination is also approved for all patients who have comorbidities that preclude use of intensive induction chemotherapy.
The approval was based on results from the phase 3 AGILE trial, which assessed the combination