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Drug ReportsGemtuzumab
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
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
mylotargBiologic Licensing Application2025-08-01
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX02: Gemtuzumab ozogamicin
HCPCS
Code
Description
J9203
Injection, gemtuzumab ozogamicin, 0.1 mg
Clinical
Clinical Trials
119 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470—C92.011———1
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGemtuzumab
INNgemtuzumab
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 classmonoclonal antibodies
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108342
ChEBI ID—
PubChem CID—
DrugBankDB00056
UNII ID8GZG754X6M (ChemIDplus, GSRS)
Target
Agency Approved
CD33
CD33
Organism
Homo sapiens
Gene name
CD33
Gene synonyms
SIGLEC3
NCBI Gene ID
945
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
P20138
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 4,546 documents
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Safety
Black-box Warning
Black-box warning for: Mylotarg
Adverse Events
Top Adverse Reactions
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3,130 adverse events reported
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