Licensure of Gemtuzumab Ozogamicin for the Treatment of Selected Patients 60 Years of Age or Older with Acute Myeloid Leukemia in First Relapse

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Abstract
This paper discusses background informationand the body of clinical data that has beenaccumulated to demonstrate the efficacy andsafety of gemtuzumab ozogamicin (Mylotarg®Wyeth Pharmaceuticals, Philadelphia, PA).Based on these data, gemtuzumab ozogamicinwas approved by the United States Food andDrug Administration for the treatment ofpatients with CD33-positive acute myeloidleukemia in first relapse who are 60 yearsof age or older and who are not consideredcandidates for other cytotoxicchemotherapy. The recommended dosage ofgemtuzumab ozogamicin is 9 mg/m2,administered as a 2-hour intravenousinfusion for a total of 2 doses with 14days between doses.