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On August 15, 2023, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application and granted priority review to oral ivosidenib tablets, a potent and targeted inhibitor of mutant IDH1, for the treatment of patients with IDH1-mutated relapsed/refractory (R/R) myelodysplastic syndromes (MDS).1
Oral ivosidenib has previously been approved by the FDA as a monotherapy and in combination with azacitidine for the treatment of patients aged ≥75 years or who are ineligible for intensive induction chemotherapy with newly diagnosed (ND) IDH1-mutated acute myeloid leukemia (AML).1 Oral ivosidenib was also recently approved by the European Commission for a subset of the same patient population: those with IDH1R132 mutations.1
This supplemental new drug application is based on results from a multicenter, open-label, phase I study (NCT02074839), previously covered by the MDS Hub, that found oral ivosidenib produced durable remissions and an acceptable safety profile in patients with R/R IDH1-mutated MDS.1
Updates from #ASCO23 and EHA on the efficacy and safety of ivosidenib, including molecular characterization and long-term follow-up in patients with mutant IDH1 AML and R/R MDS
At the ASCO and EHA congresses, updates were presented on the efficacy...
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The mutational landscape in patients with MDS/CMML and systemic inflammatory and autoimmune diseases
Up to a fifth of patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) also have a diagnosis of systemic...
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