Gemtuzumab Ozogamicin for Pediatric Acute Myeloid Leukemia: Alan S. Gamis, MD, MPH

In this interview, Alan S. Gamis, MD, MPH, speaks with i3 Health about the recent FDA approval of gemtuzumab ozogamicin (MylotargTM, Wyeth Pharmaceuticals, LLC) for pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Dr. Gamis, lead investigator of the phase 3 Children's Oncology Group Trial AAML0531, which provided the basis for the approval, discusses the significance of the approval and shares his advice for health care providers as they ...
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Gemtuzumab Ozogamicin Approved for Pediatric Acute Myeloid Leukemia

The FDA has extended the approval of gemtuzumab ozogamicin (MylotargTM, Wyeth Pharmaceuticals, LLC) to include pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Gemtuzumab ozogamicin is a humanized immunoconjugate that targets CD33, a cell surface antigen present in over 80% of patients with AML. The approval was based on AAML0531 (NCT00372593), a phase 3 trial that enrolled 1,063 patients aged 0 to 29 years with newly diagnosed AML. Patie...
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