Posted by Michael Wonder on 01 Jun 2017
Jazz Pharmaceuticals announces FDA acceptance of NDA for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia, with priority review status
31 May 2017 - Jazz Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently submitted new drug application for Vyxeos (cytarabine and daunorubicin) liposome injection, an investigational treatment for acute myeloid leukaemia, a rapidly progressing and life-threatening blood cancer.
The submission includes clinical data from five studies, including the pivotal Phase 3 study. Data from the Phase 3 study, which met its primary endpoint, were presented at the American Society of Clinical Oncology Annual Meeting in June 2016.
Vyxeos received breakthrough therapy designation from the FDA in May 2016 for the treatment of adults with therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes. Vyxeos was also granted fast track designation for the treatment of elderly patients with secondary AML by the FDA, and orphan Ddrug Designation by the FDA and the European Commission for the treatment of AML.
