FDA Approves Enasidenib for IDH2-Mutated AML

August 1, 2017 – The FDA has approved enasidenib as a treatment for patients with relapsed or refractory IDH2-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection of the IDH2 mutation. In the 199-patient phase I/II study, known AG221-C-001, enasidenib demonstrated a complete remission (CR) rate of 19.3% in patients with relapsed or refractory … (leggi tutto)