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Name
Gemtuzumab Ozogamicin
Alternate Names
Anti-CD33 Monoclonal Antibody Calicheamicin
CDP 771
CDP-771
CDP771
CMA-676
hP67.6-calicheamicin
Mylotarg
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
Targeted therapy
NSC Number
720568
716236
Primary Site
Leukemia
Histology
None
Remarks
June 16, 2020: The FDA extended the indication of gemtuzumab ozogamicin (MYLOTARGTM) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.
September 1, 2017: FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Monoclonal antibody. Gemtuzumab ozogamicin consists of a recombinant humanized anti-CD33 MAb conjugated to calicheamicin, a cytotoxic antibiotic. FDA approved for use on acute nonlymphocytic leukemia.
September 1, 2017: FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Monoclonal antibody. Gemtuzumab ozogamicin consists of a recombinant humanized anti-CD33 MAb conjugated to calicheamicin, a cytotoxic antibiotic. FDA approved for use on acute nonlymphocytic leukemia.
Coding
This drug should be coded
