The Food and Drug Administration has approved ivosidenib () as the first treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) and an isocitrate dehydrogenase-1 (IDH1) mutation.
More specifically, the oral treatment has been approved for patients whose mutations have been identified by the Abbott RealTime IDH1 assay, a companion diagnostic test.
Thewas based on results from a phase 1, open-label, single-arm, multicenter, dose-escalation and expansion trial of adult patients in this AML population. The primary end point was combined complete remission and complete remission with partial hematologic improvement; this combined rate was 32.8%, and the median duration of this remission was 8.2 months.
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation, FDA press release.
This Week's Must Reads
Must Reads in AML
IDH-mutated AML: First-line IDH inhibitors, chemo may up remission, Stein EM et al. ASH 2018, Abstract 560
Rapid genomic results possible, Beat AML trial suggests, Burd A et al. ASH 2018, Abstract 559
Phase 2 results for combo therapy in relapsed AML, Daver N et al. Cancer Discov. 2018 Nov 8. doi: 10.1158/2159-8290.CD-18-0774