On the 3rd August, 2017, The U.S. Food and Drug Administration approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.
“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Richard Pazdur, M.D., 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.”
The FDA granted the approval of Vyxeos to Jazz Pharmaceuticals.
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