FDA Approval Alert: First Treatment for Two Types of AML


The US Food and Drug Administration (FDA) has approved the first fixed-combination therapy for newly-diagnosed, poor-prognosis types of acute myeloid leukemia (AML).


Related Content

FDA Approval Alert: Therapy Approved for AML With Specific Mutation

Neoadjuvant Chemotherapy Impact on AML


Vyxeos (daunorubicin plus cytarabine, Jazz Pharmaceuticals) has been approved to treat adults with two types of AML: newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). Patients with t-AML or AML-MRC have very low life expectancies.

“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release (August 3, 2017). “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 safety and efficacy of daunorubicin plus cytarabine were studied in a cohort of 309 patients with newly diagnosed t-AML or AML-MRC who randomized to receive the drug or separately administered treatments of daunorubicin and cytarabine. Patients who received the drug lived almost 4 months longer than those who received the separate treatment (median overall survival, 9.56 months vs 5.95 months, respectively).

Vyxeos is associated with hypersensitivity reactions, decreased cardiac function, and serious or fatal bleeding.—Zachary Bessette