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On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (GO) for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients ≥ 1 month of age. This approval was based on data from the AAML0531 trial (NCT00372593).1
GO was previously approved by the FDA for the treatment of adult patients with newly diagnosed CD33-positive AML. Ongoing trials AML18 and AML19 are investigating how GO should be applied in AML and whether a fractionated dosing schedule can provide benefit over a single dose.
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