The USFDA has approved oral olutasidenib for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation diagnosed by an FDA-approved IDH1 assay. The approval is backed by the success of data obtained after the completion of the 2102-HEM-101 trial.
Indication : Olutasidenib capsules for adults with relapsed or refractory AML with a susceptible IDH1 mutation Clinical trial (2102-HEM-101) data Study : Phase II, open-label, single-arm, multicenter clinical trial Patient characteristics : n=147 Adults with relapsed or refractory AML with an IDH1 mutation Intervention : Olutasidenib 150 mg PO b.i.d. until disease progression or unacceptable toxicity or hematopoietic stem cell transplantation The median treatment duration : 4.7 months (range: 0.1 - 26 months) Efficacy endpoints CR: Rate of complete remission ; CRh: Complete remission with partial…
