FDA Approves New Treatment Option for Poor-Prognosis AML

The US Food and Drug Administration has approved Vyxeos, a fixed-combination of daunorubicin and cytarabine, for the treatment of adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or acute myeloid leukemia with myelodysplasia-related changes (AML-MRC).

Approval was based on results from a randomized trial that included 309 patients with newly diagnosed t-AML or AML-MRC. Participants received either Vyxeos or separately administered treatments of daunorubicin and cytarabine. Overall, those who received Vyxeos had a median overall survival of 9.56 months compared with patients who received separate treatments of daunorubicin and cytarabine (5.95 months).
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Common adverse effects associated with Vyxeos included hemorrhage, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, and vomiting. Serious and fatal bleeding events have been associated with Vyxeos, and necrosis has been associated with daunorubicin.

Patients with a history of serious hypersensitivity to daunorubicin, cytarabine or any component used in the formulation of Vyxeos are not recommended to receive this treatment. In addition, patient who receive Vyxeos should be monitored for hypersensitivity reactions and decreased cardiac function.

Additionally, Vyxeos includes a boxed warning to not interchange this treatment with other daunorubicin- and/or cytarabine-containing products. 

—Melissa Weiss


FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia [press release]. FDA. August 3, 2017. Accessed August 3, 2017.