Gemtuzumab
Mylotarg (gemtuzumab) is an antibody pharmaceutical. Gemtuzumab was first approved as Mylotarg on 2018-04-19. It has been approved in Europe to treat myeloid leukemia acute. The pharmaceutical is active against myeloid cell surface antigen CD33.
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Commercial
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Drug Products
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mylotarg | Biologic Licensing Application | 2025-12-19 |
Indications
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HCPCS
Code | Description |
|---|---|
| J9203 | Injection, gemtuzumab ozogamicin, 0.1 mg |
Clinical
Clinical Trials
119 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 25 | 58 | 22 | 2 | 7 | 100 |
| Leukemia | D007938 | — | C95 | 8 | 35 | 14 | 1 | 4 | 54 |
| Electrocardiography | D004562 | EFO_0004327 | — | — | — | — | 1 | — | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | — | 1 |
| Intravenous infusions | D007262 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 20 | 5 | — | — | 26 |
| Myeloid leukemia | D007951 | — | C92 | 5 | 18 | 6 | — | 1 | 23 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | 6 | 4 | — | 1 | 10 |
| Monocytic leukemia acute | D007948 | — | — | 1 | 7 | 4 | — | — | 10 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 1 | 7 | 4 | — | — | 10 |
| Preleukemia | D011289 | — | — | 2 | 7 | 3 | — | — | 9 |
| Megakaryoblastic leukemia acute | D007947 | — | C94.2 | 1 | 6 | 4 | — | — | 9 |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 1 | 6 | 4 | — | — | 9 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | 5 | 1 | — | 1 | 7 |
| Recurrence | D012008 | — | — | 2 | 5 | 1 | — | — | 7 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | — | 2 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 2 | — | — | — | 2 |
| Blast crisis | D001752 | — | — | — | 2 | — | — | — | 2 |
| Philadelphia chromosome | D010677 | — | — | — | 1 | — | — | — | 1 |
| Myeloid sarcoma | D023981 | — | C92.3 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Disease progression | D018450 | — | — | — | 1 | — | — | — | 1 |
| Homologous transplantation | D014184 | — | — | 1 | 1 | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 1 | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 2 | — | — | — | — | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gemtuzumab |
| INN | gemtuzumab |
| Description | Gemtuzumab ozogamicin, sold under the brand name Mylotarg, is an antibody-drug conjugate (a drug-linked monoclonal antibody) that is used to treat acute myeloid leukemia.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108342 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00056 |
| UNII ID | 8GZG754X6M (ChemIDplus, GSRS) |
Target
Agency Approved
CD33
CD33
Organism
Homo sapiens
Gene name
CD33
Gene synonyms
SIGLEC3
NCBI Gene ID
Protein name
myeloid cell surface antigen CD33
Protein synonyms
CD33, CD33 antigen (gp67), CD33 molecule transcript, gp67, Sialic acid-binding Ig-like lectin 3, Siglec-3
Uniprot ID
Mouse ortholog
Cd33 (12489)
myeloid cell surface antigen CD33 (Q63997)
Alternate
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Variants
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Trends
PubMed Central
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Additional graphs summarizing 5,221 documents
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Safety
Black-box Warning
Black-box warning for: Mylotarg
Adverse Events
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3,197 adverse events reported
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