Licensure of gemtuzumab ozogamicin for the treatment of selected patients 60 years of age or older with acute myeloid leukemia in first relapse

This paper discusses background information and the body of clinical data that has been accumulated to demonstrate the efficacy and safety of gemtuzumab ozogamicin (Mylotarg(R), Wyeth Pharmaceuticals, Philadelphia, PA). Based on these data, gemtuzumab ozogamicin was approved by the United States Food and Drug Administration for the treatment of patients with CD33-positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The recommended dosage of gemtuzumab ozogamicin is 9 mg/m(2), administered as a 2-hour intravenous infusion for a total of 2 doses with 14 days between doses.