Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the initial treatment of adults with acute myeloid leukaemia who are not candidates for standard induction chemotherapy.
The marketing authorisation application is supported by results from the Phase 3 ASCERTAIN clinical trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous decitabine.
