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Erbitux(cetuximab)
Erbitux (cetuximab) is an antibody pharmaceutical. Cetuximab was first approved as Erbitux on 2004-02-12. It is used to treat squamous cell carcinoma in the USA. It has been approved in Europe to treat colorectal neoplasms and head and neck neoplasms. The pharmaceutical is active against epidermal growth factor receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
Trade Name
FDA
EMA
Erbitux
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)
Cetuximab
Tradename
Proper name
Company
Number
Date
Products
ErbituxcetuximabEli LillyN-125084 RX2004-02-12
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
erbituxBiologic Licensing Application2021-02-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
squamous cell carcinoma—D002294—
Agency Specific
FDA
EMA
Expiration
Code
cetuximab, Erbitux, Eli Lilly and Company
2113-03-01Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FE: Egfr (epidermal growth factor receptor) inhibitors
— L01FE01: Cetuximab
HCPCS
Code
Description
J9055
Injection, cetuximab, 10 mg
Clinical
Clinical Trials
831 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD0151797018044317278
Head and neck neoplasmsD00625835791427125
NeoplasmsD009369C80563521—77
Neoplasm metastasisD009362EFO_00097083822—13
Liver neoplasmsD008113EFO_1001513C22.034—1—7
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Squamous cell carcinoma of head and neckD000077195476920—4118
Non-small-cell lung carcinomaD00228923415——58
Rectal neoplasmsD01200414221—234
Colonic neoplasmsD003110C1817163—133
Squamous cell carcinomaD00229413193—430
Pancreatic neoplasmsD010190EFO_0003860C2511211—230
Squamous cell neoplasmsD0183079232—227
Esophageal neoplasmsD004938C156213——24
Lung neoplasmsD008175C34.904161——20
AdenocarcinomaD0002306143——18
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50810———16
Verrucous carcinomaD01828975——111
Salivary gland neoplasmsD012468EFO_0003826D1175———10
Tongue neoplasmsD014062EFO_0003871C02.964——110
Uterine cervical neoplasmsD00258338———9
GlioblastomaD005909EFO_000051555———7
Renal cell carcinomaD00229256———7
Ovarian neoplasmsD010051EFO_0003893C5634———6
GliomaD005910EFO_000052034———5
CholangiocarcinomaD018281C22.1—5———5
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD0085453————3
Thyroid neoplasmsD013964EFO_00038412————2
Healthy volunteers/patients—2————2
Kidney neoplasmsD007680EFO_0003865C641————1
Digestive system neoplasmsD0040671————1
Respiratory tract neoplasmsD012142EFO_0003853D141————1
Castleman diseaseD005871EFO_1001332D47.Z21————1
Soft tissue neoplasmsD0129831————1
Neurofibromatosis 2D016518Q85.021————1
Erdheim-chester diseaseD0312491————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Deglutition disordersD003680HP_0002015R13.1————11
Mass spectrometryD013058————11
Drug resistanceD004351Z16.30————11
RadiotherapyD011878————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCETUXIMAB
INNcetuximab
Description
Immunoglobulin G 1 (human-mouse monoclonal C225 yt-chain anti-human epidermal growth factor receptor), disulfide with human-mouse monoclonal C225 x-chain, dimer
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)CETUXIMAB
Structure (InChI/SMILES or Protein Sequence)
>5GZ0:A,C|FM329 light chain DIQMTQSPVILSVSPGERVSFSCRASQSIGTNIHWYQQRTNGSPRLLIKYASESISGIPSRFSGSGSGTDFTLSINSVES EDIADYYCQQNNNWPTTFGAGTKLELKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGAEC >5GZ0:B,D|FM329 heavy chain QVQLKQSGPGLVQPGGSLSITCTVSGFSLTNYGVHWVRQSPGKGLEWLGVIWSGGNTDYNTPFTSRLSINKDNSKSQVFF KMNSLQSNDTAIYYCARALTYYDYEFAYWGQGTLVTVSAASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSW NSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDK
Identifiers
PDB1YY8, 1YY9, 4GW5, 4KRO, 4KRP, 5ESQ, 5ETU, 5EUK, 5F88, 5FF6, 5GZ0, 5HPM, 5HYQ, 5I2I, 5I76, 5ICX, 5ICY, 5ICZ, 5ID0, 5ID1, 5IOP, 5IR1, 5ITF, 5IV2, 5IVZ, 5T1K, 5T1L, 5T1M, 5TH2, 6ARP, 6ARU, 6AU5, 6AXP, 6AYN, 6AZK, 6AZL, 6B3S
CAS-ID205923-56-4
RxCUI318341
ChEMBL IDCHEMBL1201577
ChEBI ID—
PubChem CID—
DrugBankDB00002
UNII IDPQX0D8J21J (ChemIDplus, GSRS)
Target
Agency Approved
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
1956
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Erbitux - Eli Lilly
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£
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Erbitux - Bristol Myers Squibb
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 38,526 documents
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Safety
Black-box Warning
Black-box warning for: Erbitux
Adverse Events
Top Adverse Reactions
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482 adverse events reported
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