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WASHINGTON -- The FDA today approved the fixed-dose combination drug Vyxeos (daunorubicin/cytarabine) for patients with newly diagnosed treatment-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (MRC).

The approval is the first ever for a treatment specific to the two high-risk subtypes of AML. About 10% of patients with treated cancers develop t-AML as a complication of chemotherapy or radiation therapy. Patients AML-MRC have a history of blood disorders and significant mutations in cancer cells. Both subtypes of AML have a poor prognosis associated with low life expectancy.

Supporting data for the approval came primarily from a randomized trial involving patients with newly diagnosed t-AML or AML-MRC. Patients received either the fixed-dose combination or the same drugs administered separately. Patients who received the fixed combination had a median survival of 9.56 months compared with 5.95 months for those who received the drugs separately.

Common side effects of the combination drug include hemorrhage, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmias, pneumonia, bacteremia, chills, sleep disorders, and vomiting.

"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," Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement.

The approval came with a boxed warning against using or interchanging the combination drug with other products containing daunorubicin and/or cytarabine.

The FDA previously designated Vyxeos for priority review, breakthrough therapy, and orphan drug status. The approval was granted to Jazz Pharmaceuticals.

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