What is the role of gemtuzumab ozogamicin (Mylotarg) in the treatment of relapsed acute myeloid leukemia (AML)?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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In September 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg) for the treatment of patients aged 2 years and older with relapsed or refractory AML whose tumors express the CD33 antigen (CD33-positive AML). [54]  The dosage for these patients is 3 mg/m2 on days 1, 4 and 7. Differences in CD33 expression (with lower levels seen in cases with adverse karyotype and core-binding factor AML, and higher expression seen in AML with mutations in FLT3MLL or NPM1) and CD33 splicing polymorphisms are factors influencing response rates [102] .

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