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FDA approves first treatment for certain types of poor-prognosis AML

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FDA has approved a fixed combination of two chemotherapies, daunorubicin and cytarabine (Vyxeos—Jazz Pharmaceuticals), for the treatment of adults with two types of acute myeloid leukemia (AML). The two AML types are newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC).

FDA has approved a fixed combination of two chemotherapies, daunorubicin and cytarabine (Vyxeos—Jazz Pharmaceuticals), for the treatment of adults with two types of acute myeloid leukemia (AML). The two AML types are newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). "This is the first approved treatment specifically for patients with certain types of high-risk AML," said Richard Pazdur, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in 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." A randomized trial of more than 300 patients with newly diagnosed t-AML or AML-MRC found that patients who received the fixed chemotherapy combination had a median overall survival of 9.56 months, compared with 5.95 months for those who received separately administered treatments of daunorubicin and cytarabine. Common adverse effects of the combination treatment include bleeding events, fever with low white blood cell count, rash, swelling of the tissues, nausea, inflammation of the mucous membranes, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, shortness of breath, headache, cough, decreased appetite, abnormal heart rhythm, lung infection, blood infection, chills, sleep disorders, and vomiting. Patients with a history of serious hypersensitivity to daunorubicin, cytarabine, or any component of the formulation should not use the fixed-combination treatment. The product's prescribing information also includes a boxed warning not to interchange it with other daunorubicin- and/or cytarabine-containing products.

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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm

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