General AML

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

On 31st 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.

  1. PRNewswire: Jazz Pharmaceuticals Announces FDA Acceptance of NDA for VYXEOS™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status. 2017 May 31. [Accessed 2017 Jun 1].
  2. Lancet J.E. et al. Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. Oral Abstract #7000. American Society of Clinical Oncology Meeting 2016.
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