FDA approves Vyxeos for acute myeloid leukemia

SILVER SPRING, Md. — A new treatment for certain types of acute myeloid leukemia has been cleared by the Food and Drug Administration. Jazz Pharmaceuticals’ Vyxeos was approved for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes

 

“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Dr. 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 Center for Drug Evaluation and Research. “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.”

 

Vyxeos is the first product to be developed using Jazz Pharmaceuticals’ proprietary CombiFlex platform, which it said enables the design and rapid evaluation of various combinations of therapies.  The company said it expects to make Vyxeos available within a week. 

 

"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes," Jazz chairman and CEO Bruce Cozadd said. "The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community."