OBR OncologyFDA OKs Olutasidenib (Rezlidhia) for Relapsed/Refractory Acute Myeloid Leukemia with IDH1 Mutation

Data from Study 2102-HEM-101, an open-label, single-arm, multicenter phase 1/2 trial, were used to support the approval. The Abbott RealTime IDH1 Assay was used to identify 147 adults with relapsed or refractory AML who had an IHD1 mutation. Olutasidenib treatment resulted in a 35% complete remission (CR) or complete remission with partial hematologic recovery in patients (CRh).