FDA approves Tibsovo for myelodysplastic syndromes

The US Food and Drug Administration yesterday approved Tibsovo (ivosidenib), from French independent pharm major Servier, 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 approved Tibsovo for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, in May last year. In May this year, Servier also has secured European approval for Tibsovo (ivosidenib) in two indications, making it the first and only IDH1 blocker to be available in the region.

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