FDA accepts for priority review New Drug Application for combination oral cedazuridine and decitabine (oral C-DEC) for previously untreated intermediate- and high-risk myelodysplastic syndromes including chronic myelomonocytic leukaemia (CMML)

C-DEC is novel, orally administered fixed dose combination of cedazuridine, an inhibitor of cytidine deaminase, with the DNA hypomethylating agent, decitabine (DEC). Submission is based on ASCERTAIN phase 3 study evaluating 5-day DEC exposure equivalence of oral C-DEC and IV DEC.


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