Posted by Michael Wonder on 12 Feb 2020
Astex Pharmaceuticals announces U.S. 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
11 February 2020 - FDA designated the application for priority review.
Astex Pharmaceuticals today announced that the U.S. FDA has accepted for priority review its new drug application for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML.
The submission is based on data from the ASCERTAIN phase 3 study which evaluated the 5-day decitabine exposure equivalence of oral C-DEC and IV decitabine.
