FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

Gemtuzumab ozogamicin (GO) 3 mg/m² days 1, 4, and 7 is an active regimen for induction of remission when used to treat patients with relapsed or refractory CD33-positive acute myeloid leukemia without curative intent. The risks of hepatic veno-occlusive disease and early mortality with this regimen appear to be lower than reported previously for GO 9 mg/m² days 1 and 15. The data were not sufficient to enable conclusions about the safety of GO in children younger than 2 years of age.