FDA Approves New Treatment for Acute Myeloid Leukemia
THURSDAY, Aug. 3, 2017 -- The combination chemotherapy drug Vyxeos (daunorubicin and cytarabine) has been approved by the U.S. Food and Drug Administration as the first treatment for certain high-risk types of acute myeloid leukemia (AML).
The new therapy is sanctioned for high-risk forms of newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes. Vyxeos was evaluated in clinical trials involving 309 patients with either form of AML. Those given Vyxeos lived an average of 9.6 months, compared to 5.9 months among those who took an inactive placebo.
The therapy's most common side effects included bleeding, febrile neutropenia, rash, edema, and nausea. Some users had episodes of serious allergic-like hypersensitivity reactions or dangerous bleeding, the agency said.
"This is the first approved treatment specifically for patients with certain types of high-risk AML," 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, said in a statement. "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."
Approval of the drug was granted to the Irish firm Jazz Pharmaceuticals.
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Posted: August 2017