| Drug Name |
Gemtuzumab ozogamicin |
| Drug ID |
BADD_D01015 |
| Description |
Gemtuzumab ozogamicin is a recombinant humanized IgG4 kappa antibody which is conjugated with calicheamicin derivative, a cytotoxic antitumor antibiotic isolated from fermentation of Micromonospora echinospora ssp. calichensis. Gemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody [FDA Label]. The antibody is specifically directed against the CD33 antigen present on leukemic myeloblasts in most patients with acute myeloid leukemia (AML). By binding to the CD33 antigen on tumors, the cytotoxic agent blocks the growth of cancerous cells and causes cell death.
Marketing approval of gemtuzumab ozogamicin was granted on May 17, 2000 by FDA as a treatment for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy [A98]. However, it was voluntarily withdrawn from the market in 2010 due to safety concerns, increased patient deaths and insufficient evidence of clinical benefit during confirmatory trials [L941]. On September 1 2017, gemtuzumab ozogamicin was again approved for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia but with a lower dosing regimen and a different schedule in combination with chemotherapy or on its own [L941]. It is also indicated 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) [L941]. |
| Indications and Usage |
Indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. Indicated 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). |
| Marketing Status |
approved; investigational |
| ATC Code |
L01FX02 |
| DrugBank ID |
DB00056
|
| KEGG ID |
D03259
|
| MeSH ID |
D000079982
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
D06EWO
|
| NDC Product Code |
0008-4510 |
| UNII |
8GZG754X6M
|
| Synonyms |
Gemtuzumab | Mylotarg | Gemtuzumab Ozogamicin | Gemtuzumab-Ozogamicin | CMA 676 | CMA-676 | CMA676 |
