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

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