FDA Grants Ivosidenib Priority Review for Frontline IDH1+ AML

February 20, 2019 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for ivosidenib for the frontline treatment of patients IDH1-mutant acute myeloid leukemia (AML) who are ineligible for standard chemotherapy. The sNDA is based on data from a phase I trial in which ivosidenib induced an overall response rate (ORR) of 57.6% (95% CI, 39.2-74.5) among newly diagnosed patients with IDH1-positive AML. The ORR included … (leggi tutto)