FDA accepts filing of Vyxeos (cytarabine and daunorubicin) liposome injection to treat acute myeloid leukemia. - Jazz Pharmaceuticals

Jazz Pharmaceuticals plc announced that the FDA has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Vyxeos (cytarabine and daunorubicin) liposome injection, an investigational treatment for acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer. Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. The granting of Priority Review for the Vyxeos NDA accelerates the timing of the FDA review of the application compared to a standard review.

The NDA submission includes clinical data from five studies, including the pivotal Phase III study. Data from the Phase III 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 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 Drug Designation by the FDA and the European Commission for the treatment of AML.