FDA Approves Ivosidenib for Frontline IDH1+ AML

May 2, 2019 – The FDA has approved a supplemental new drug application (sNDA) for ivosidenib as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia (AML), as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy. The approval is based on findings from a phase I trial in which ivosidenib induced a 28.6% (95% CI, 13.2-48.7) complete response (CR) rate and a CR plus … (leggi tutto)