Vyxeos (cytarabine and daunorubicin liposome injection) in a rolling submission to FDA for acute myeloid leukemia- Jazz Pharma

Jazz Pharmaceuticals announced the initiation of a rolling submission of a New Drug Application (NDA) to the FDA on September 30, 2016, seeking marketing approval of Vyxeos (cytarabine and daunorubicin liposome injection), an investigational agent for the treatment of acute myeloid leukemia (AML). The company expects to complete the submission of the NDA by early 2017, and will request a priority review.

Comment: Vyxeos was granted Breakthrough Therapy Designation in May 2016 for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. Celator Pharmaceuticals, Inc. completed and announced the results of its Phase III trial evaluating Vyxeos in patients with high-risk AML in March 2016. Jazz Pharmaceuticals completed the acquisition of Celator Pharmaceuticals in July 2016.