FDA Approves Treatment for Acute Myeloid Leukemia

AUGUST 03, 2017
Officials with the FDA have approved daunorubicin and cytarabine (Vyxeos, Jazz Pharmaceuticals) for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). V

The safety and efficacy of Vyxeos were studied in 309 patients with newly diagnosed t-AML or AML-MRC who were randomly assigned to receive Vyxeos or separately administered treatments of daunorubicin and cytarabine. The trial measured how long patients lived from the date they started the trial (overall survival). Patients who received Vyxeos lived longer than patients who received separate treatments of daunorubicin and cytarabine (median overall survival 9.56 months vs. 5.95 months).

Common side effects of Vyxeos include bleeding events (hemorrhage), fever with low white blood cell count (febrile neutropenia), rash, swelling of the tissues (edema), nausea, inflammation of the mucous membranes (mucositis), diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, shortness of breath (dyspnea), headache, cough, decreased appetite, abnormal heart rhythm (arrhythmia), lung infection (pneumonia), blood infection (bacteremia), chills, sleep disorders and vomiting.

Patients who have a history of serious hypersensitivity to daunorubicin, cytarabine or any component of the formulation should not use Vyxeos. Patients taking Vyxeos should be monitored for hypersensitivity reactions and decreased cardiac function. Vyxeos has been associated with serious or fatal bleeding events. Daunorubicin has been associated with severe damage (necrosis) where the drug leaks into the skin and subcutaneous tissue from the intravenous infusion (extravasation). Women who are pregnant or breastfeeding should not take Vyxeos, because it may cause harm to a developing fetus or a newborn baby.

The prescribing information for Vyxeos includes a boxed warning not to interchange Vyxeos with other daunorubicin- and/or cytarabine-containing products. 

“This is the first approved treatment specifically for patients with certain types of high-risk AML,” Richard Pazdur, MD, 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 press release. “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.”

Reference
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia [news release]. FDA website. Accessed Aug. 3, 2017 at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm.  
 

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