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Margetuximab
Margenza (margetuximab) is an antibody pharmaceutical. Margetuximab was first approved as Margenza on 2020-12-16. The pharmaceutical is active against receptor tyrosine-protein kinase erbB-2.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Margenza
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)
Margetuximab
Tradename
Proper name
Company
Number
Date
Products
Margenzamargetuximab-cmkbMacroGenics Inc.N-761150 RX2020-12-16
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
margenzaBiologic Licensing Application2021-01-21
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code
Description
J9353
Injection, margetuximab-cmkb, 5 mg
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C502417
Stomach neoplasmsD013274EFO_0003897C162213
NeoplasmsD009369C80112
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Esophageal neoplasmsD004938C15111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD01933711
Ovarian neoplasmsD010051EFO_0003893C5611
Non-small-cell lung carcinomaD00228911
Triple negative breast neoplasmsD06472611
Squamous cell carcinoma of head and neckD00007719511
Uterine cervical neoplasmsD00258311
Small cell lung carcinomaD05575211
CholangiocarcinomaD018281C22.111
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMARGETUXIMAB
INNmargetuximab
Description
Margetuximab (chimeric mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID1350624-75-7
RxCUI
ChEMBL IDCHEMBL2364649
ChEBI ID
PubChem CID
DrugBankDB14967
UNII IDK911R84KEW (ChemIDplus, GSRS)
Target
Agency Approved
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 496 documents
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Safety
Black-box Warning
Black-box warning for: Margenza
Adverse Events
Top Adverse Reactions
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2,545 adverse events reported
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