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Ivosidenib Approved for IDH1-Mutant Myelodysplastic Syndromes With Amir Fathi, MD

Recently, the FDA approved ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. In this interview, Amir Fathi, MD, Director of the Leukemia Program at Massachusetts General Hospital, one of the leaders of the AG120-C-001 trial (NCT02074839), on which approval was based, sat down to further discuss the trial and approval, as well as what this could mean for the future treatment landscape of MDS. &n...

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Ivosidenib Approved for IDH1-Mutant Relapsed or Refractory Myelodysplastic Syndromes

The FDA has approved ivosidenib (Tibsovo┬«, Servier Pharmaceuticals LLC) 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. In addition, the FDA approved a companion diagnostic device, Abbott RealTime IDH1 Assay, to select patients for ivosidenib.   Why it matters: "Mutations in IDH1 occur in ~3% of patients with MDS and are associated with increased transformation ...

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