The FDA accepts New Drug Application for Vyxeos® for the treatment of AML and grants Priority Review status

On 31^st May 2017, the U.S. Food and Drug Administration (FDA) accepted the recently filed New Drug Application (NDA) for Vyxeos® (CPX351), a liposomal formulation of cytarabine plus daunorubicin co-encapsulated at a molar ratio of 5:1, for the treatment of patients with Acute Myeloid Leukemia (AML). In addition to the NDA acceptance, Vyxeos® was also granted priority review status by the FDA¹

The NDA submission was based on clinical data from five studies including a pivotal phase III study (NCT01696084), which was presented at the American Society of Clinical Oncology meeting 2016 by Jeffrey E. Lancet from the Lee Moffitt Cancer Center & Research Institute, Florida, USA, and colleagues. The results of the phase III study showed that CPX-351 improved the survival of older patients with AML.²

CPX-351 is currently being explored in multiple studies in patients with newly diagnosed and relapsed/refractory AML.