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FDA Alerts

FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Adults with Some Types of Poor Prognosis AML

The U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis. This is the first FDA-approved treatment specifically for patients with t-AML or AML-MRC.