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2023-08-17T09:49:01.000Z

FDA grants priority review and accepts supplemental new drug application for oral ivosidenib for the treatment of patients with IDH1-mutated R/R MDS

Aug 17, 2023
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Learning objective: After reading this article, learners will be able to cite a new development in IDH1-mutated relapsed/refractory myelodysplastic syndromes

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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

  1. Cision PR Newswire. Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in the Treatment of IDH1-mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS). https://www.prnewswire.com/news-releases/servier-announces-fda-filing-acceptance-and-priority-review-for-tibsovo-ivosidenib-tablets-in-the-treatment-of-idh1-mutated-relapsed-or-refractory-rr-myelodysplastic-syndromes-mds-301901315.html. Published Aug 15, 2023. Accessed Aug 16, 2023.

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