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

Jun 1, 2017

On 31 stMay 2017, the U.S. Food and Drug Administration(FDA) accepted the recentlyfiled 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 FDA 1

The NDA submission was based on clinical data from five studies including a pivotal phase III study ( NCT01696084), which was presentedat the American Society of Clinical Oncologymeeting 2016 by Jeffrey E. Lancetfrom 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. http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-acceptance-of-nda-for-vyxeos-cpx-351-an-investigational-treatment-for-acute-myeloid-leukemia-with-priority-review-status-300466520.html[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 OncologyMeeting 2016.

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