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Synonyms: CDP 771 | CMA 676 | hP67.6-calicheamicin | Mylotarg® | WAY-CMA 676
gemtuzumab ozogamicin is an approved drug (FDA (2000), EMA (2018))
Compound class: Antibody
Comment: This drug is an antibody-drug conjugate (ADC) that targets delivery of the highly cytotoxic ozogamicin (a derivative of calicheamicin γ1) to CD33 +ve myeloid cells .
|No information available.|
|Summary of Clinical Use|
|Used to treat CD33-positive acute myeloid leukemia (AML) in patients over 60 who are not candidates for other chemotherapy. Note that as requested by the US FDA, the drug was withdrawn from the US market in 2010, due to questions over its effectiveness and safety. Other international regulatory authorities still approved use of this drug.
In September 2017, after careful reveiw, the FDA approved gemtuzumab ozogamicin for two new uses:
1. Initial use in adults whose AML tumours express the CD33 antigen.
2. For patients aged ≥2 years with relapsed or refractory CD33-positive AML.
In June 2020 FDA approval was expanded to include pediatric patients ≥1 month old, with newly-diagnosed CD33-positive AML
|Mechanism Of Action and Pharmacodynamic Effects|
|Antineoplastic conjugate of anti-CD33 antibody and the cytotoxic antibacterial calicheamicin γ1. The conjugate binds to the cell surface receptor and is rapidly internalised, subsequently the calicheamicin γ1 binds to the minor groove of DNA molecules and causes DNA double-strand breaks which triggers apoptosis.|
|Clinical Trial ID||Title||Type||Source||Comment||References|
|NCT00372593||Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia||Phase 3 Interventional||Children's Oncology Group||2|
For extended ADME data see the following:
Electronic Medicines Compendium (eMC)
European Medicines Agency (EMA)