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Gemtuzumab ozogamicin (GO; Mylotarg) is a drug–monoclonal antibody conjugate that delivers the cytotoxic agent chalicheamicin to acute myeloid leukemia (AML) cells by targeting the myeloid surface protein CD33. The agent was approved for AML therapy following positive clinical study results, but was withdrawn after a phase III trial showed that it provided no clear benefit and increased mortality.
To test a modified fractionated GO dosing schedule, French investigators conducted a randomized, phase III trial involving 278 patients (aged 50–70) with newly diagnosed AML. Patients with myeloproliferative disorder or myelodysplastic syndrome (MDS) were excluded. Patients received “7+3” cytarabine (200 mg/m2 for 7 days) plus daunorubicin (60 mg/m…