Mylotarg(gemtuzumab ozogamicin)
Mylotarg (gemtuzumab ozogamicin) is an antibody drug conjugate pharmaceutical. Gemtuzumab ozogamicin was first approved as Mylotarg on 2017-09-01. It is used to treat myeloid leukemia acute and myelomonocytic leukemia acute in the USA. 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
Trade Name
FDA
EMA
Mylotarg
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mylotarg | Biologic Licensing Application | 2025-08-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
| myelomonocytic leukemia acute | — | D015479 | C92.5 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
gemtuzumab ozogamicin, Mylotarg, Wyeth Pharmaceuticals LLC | |||
| 2024-09-01 | Orphan excl. | ||
Patent Expiration
No data
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 | 57 | 22 | 2 | 7 | 99 |
| Leukemia | D007938 | — | C95 | 9 | 39 | 14 | 1 | 6 | 61 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia | D007951 | — | C92 | 6 | 22 | 6 | — | 3 | 30 |
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 20 | 5 | — | — | 26 |
| Preleukemia | D011289 | — | — | 2 | 9 | 3 | — | — | 11 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | 6 | 4 | — | 1 | 10 |
| Monocytic leukemia acute | D007948 | — | — | 1 | 7 | 4 | — | — | 10 |
| Megakaryoblastic leukemia acute | D007947 | — | C94.2 | 1 | 6 | 4 | — | — | 9 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 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 | 4 | 1 | — | — | 6 |
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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 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 2 |
| Blast crisis | D001752 | — | — | — | 2 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | — | — | 1 |
| Philadelphia chromosome | D010677 | — | — | — | 1 | — | — | — | 1 |
| Myeloid sarcoma | D023981 | — | C92.3 | — | 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 |
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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 ozogamicin |
| INN | gemtuzumab ozogamicin |
| Description | Immunoglobulin G 4 (human-mouse monocional hP67.674-chain anti-human antigen CD 33), disulfide with human-mouse monoclonal hP67.6x-chain, dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies; antibiotics (Micromonospora strains) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201506 |
| 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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,326 documents
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Safety
Black-box Warning
Black-box warning for: Mylotarg
Adverse Events
Top Adverse Reactions
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4,964 adverse events reported
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