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FDA grants priority review to Vyxeos for AML
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The FDA granted priority review to CPX-351 liposome injection for the treatment of acute myeloid leukemia, according to the drug’s manufacturer.
CPX-351 (Vyxeos, Jazz Pharmaceuticals) is a combination of cytarabine and daunorubicin encapsulated within a nanoscale liposome at a 5:1 molar ratio.
The new drug application for CPX-351 included data from five studies designed to evaluate CPX-351 in patients with AML, including a pivotal phase 3 study that met its primary endpoint.
“We are pleased by the FDA's acceptance of the new drug application filing with priority review as this action emphasizes the need for new treatments for patients living with AML,” Karen Smith, MD, PhD, executive vice president of research and development and chief medical officer at Jazz Pharmaceuticals, said in a company-issued release. “We look forward to working with the FDA during this review process to obtain approval of VYXEOS as quickly as possible, as AML is the most common of all adult leukemias and AML patients have among the lowest survival rates.”
The FDA previously granted CPX-351 breakthrough therapy designation for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes, fast track designation for the treatment of elderly patients with secondary AML, and orphan drug designation for the treatment of AML.