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FDA Grants Priority Review to Cedazuridine/Decitabine for MDS and CMML

Jason M. Broderick
Published: Thursday, Feb 13, 2020

The FDA has granted a priority review designation to a new drug application (NDA) for cedazuridine plus decitabine (ASTX727; oral C-DEC) for the treatment of adult patients with previously untreated intermediate- and high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML).1

The researchers reported that the safety data for IV decitabine were consistent with historical findings, and that the rates of adverse events (AEs) between the 2 treatment arms were similar. Among patients who received oral C-DEC in the first 2 cycles, the most common (≥20%) AEs were thrombocytopenia (43.8%), neutropenia (35.4%), anemia (36.9%), and fatigue (23.8%).

References           

  1. Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML. Published February 13, 2020. https://bit.ly/31RVFV1. Accessed February 13, 2020.           
  2. Garcia-Manero G, McCloskey J, Elizabeth Griffiths E, at al. Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross-Over Phase 3 Study (ASCERTAIN) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine. Presented at: 2019 ASH Annual Meeting; December 7-10, 2019; Orlando, FL. Abstract 846.

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