The recently submitted New Drug Application (NDA) for CPX-351 liposome injection, an investigational treatment for acute myeloid leukemia (AML), was accepted for filing by the FDA with Priority Review. CPX-351 is a combination of cytarabine and daunorubicin encapsulated within a nanoscale liposome at a 5:1 molar ratio.
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 CPX-351 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 a pivotal phase III study.
CPX-351 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. It was also granted Fast Track Designation for the treatment of elderly patients with secondary AML, and Orphan Drug Designation for the treatment of AML.