FDA offers another speedy cancer drug OK, approving Jazz’s Vyxeos for acute myeloid leukemia
In just the latest case of a cancer drug sped along by the FDA, Jazz Pharmaceuticals $JAZZ today won approval for Vyxeos (CPX-351) as a new therapy for acute myeloid leukemia.
The FDA not only provided a breakthrough therapy designation for the drug — a combination of cytarabine and daunorubicin — it also offered an abbreviated 6-month priority review for the treatment.
“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s CDER. “Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately.”
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