Posted by Michael Wonder on 24 Oct 2023
FDA approves ivosidenib for myelodysplastic syndromes
24 October 2023 - Today, the FDA approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for adult patients with relapsed or refractory myelodysplastic syndromes 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.
