FDA Approves Tibsovo for Myelodysplastic Syndromes

The FDA approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.

The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic device to select patients for ivosidenib.

Approval was based on trial AG120-C-001, an open-label, single-arm, multicenter trial of 18 adult patients with relapsed or refractory MDS