Press Announcements > FDA approves Mylotarg for treatment of acute myeloid leukemia

Press Announcements > FDA approves Mylotarg for treatment of acute myeloid leukemia

FDA approves Mylotarg for treatment of acute myeloid leukemia 09/01/2017 11:19 AM EDT The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).