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Industry News Archive

FDA Approves Inqovi Tablets for Adults with Intermediate and High-Risk Myelodysplastic Syndromes

On July 7, 2020, the U.S. Food and Drug Administration (FDA) and Health Canada have approved decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd.) tablets for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies. The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral Inqovi® and intravenous decitabine. The safety and efficacy of Inqovi® was also assessed in the clinical studies.

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Posted 7/17/2020


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