Vyxeos Granted Priority Review by FDA

The NDA is supported by data from 5 studies, including a pivotal Phase 3 study which met its primary endpoint
The NDA is supported by data from 5 studies, including a pivotal Phase 3 study which met its primary endpoint

Priority Review has been granted to the New Drug Application (NDA) for Vyxeos (cytarabine and daunorubicin; Jazz) liposome injection, a treatment being evaluated for acute myeloid leukemia (AML).

Vyxeos, or CPX-351, combines cytarabine and daunorubicin in a nano-scale liposome at a 5:1 molar ratio using the CombiPlex platform. The NDA is supported by clinical data from 5 studies, including a pivotal Phase 3 study which met its primary endpoint of statistically significant improvement in overall survival for the Vyxeos arm vs. the 7+3 arm (median 9.56 months vs. 5.95 months, respectively). Moreover, there was a 31% reduction in mortality with Vyxeos vs. the 7+3 arm (hazard ratio [HR] 0.69; P=0.005). 

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Vyxeos was granted Breakthrough Therapy Designation in May 2016 by the Food and Drug Administration (FDA) 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 older adults with secondary AML. 

For more information visit JazzPharma.com.