News from the FDA/CDC

FDA grants priority review for AML drug


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.

Ivosidenib is a first-in-class oral inhibitor of mutant IDH1. 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.

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