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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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Mock data
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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_0003869C50241——7
Stomach neoplasmsD013274EFO_0003897C16221——3
NeoplasmsD009369C801—1——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Esophageal neoplasmsD004938C1511———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD0193371————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Non-small-cell lung carcinomaD0022891————1
Triple negative breast neoplasmsD0647261————1
Squamous cell carcinoma of head and neckD0000771951————1
Uterine cervical neoplasmsD0025831————1
Small cell lung carcinomaD0557521————1
CholangiocarcinomaD018281C22.11————1
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
2064
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
P04626
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
Mock data
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2,545 adverse events reported
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