FDA to Review Vyxeos for Acute Myeloid Leukemia

The Vyxeos NDA submission was supported by data from 5 clinical studies, including one Phase 3 trial
The Vyxeos NDA submission was supported by data from 5 clinical studies, including one Phase 3 trial

Jazz Pharmaceuticals announced the completion of a rolling submission of the New Drug Application (NDA) for Vyxeos (cytarabine and daunorubicin) liposome to the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).

The NDA submission was supported by data from five clinical studies, including a pivotal Phase 3 trial which met its primary endpoint and presented at the American Society of Clinical Oncology Annual Meeting in June 2016. The company filed for the NDA with a request for priority review. 

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The FDA previously granted Vyxeos Breakthrough Therapy designation in May 2016 for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. Additionally, it also received Orphan Drug designation for the treatment of AML and Fast Track designation for the treatment of secondary AML in the elderly population.

Vyxeos (CPX-351), an investigational, liposomal injection, is developed utilizing CombiPlex technology which encapsulates a fixed ratio of cytarabine and daunorubicin in a nano-scale delivery complex.

For more information visit Jazzpharma.com.