The FDA on September 1, 2017 approved MYLOTARG® for the treatment of newly-diagnosed CD33-positive Acute Myeloid Leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. MYLOTARG® may be used in combination with Daunorubicin and Cytarabine for adults with newly diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients. MYLOTARG® is a product of Pfizer Inc.