The Food and Drug Administration has granted priority review status to ivosidenib for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation.
The drug, marketed by Agios Pharmaceuticals, was given a Prescription Drug User Free Act action date of Aug. 21, 2018.
Results from a phase 1 dose-escalation and expansion study (AG120-C-001) presented at the annual meeting of the American Society of Hematology showed a complete response and complete response with partial hematologic recovery rate of 30.4% in 125 patients with relapsed/refractory AML who received the drug, according to Agios.