Gemtuzumab ozogamicin for acute myeloid leukemia

Frederick R. Appelbaum and Irwin D. Bernstein


On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin for the treatment of adults with newly diagnosed CD33+ acute myeloid leukemia and for patients aged 2 years and older with CD33+ AML who have experienced a relapse or who have not responded to initial treatment. This signals a new chapter in the long and unusual story of gemtuzumab ozogamicin (GO), which was the first antibody-drug conjugate approved for human use by the FDA.

  • Submitted September 5, 2017.
  • Accepted October 9, 2017.