FDA approves therapy for myelodysplastic syndromes

December 2023—The FDA has approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.

Tibsovo was previously approved for certain adults with newly diagnosed acute myeloid leukemia, relapsed or refractory AML, and locally advanced or metastatic cholangiocarcinoma. The Abbott RealTime IDH1 assay was previously approved as a CDx to identify AML patients with an IDH1 mutation for treatment with Tibsovo or olutasidenib (Rezlidhia, Rigel Pharmaceuticals).

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Abbott , 800-553-7042