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Drug ReportsCetuximab
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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Study first post date
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Completion date
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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 Application2026-04-16
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
1196 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 neoplasmsD015179——13027766548460
Head and neck neoplasmsD006258——5211619222191
NeoplasmsD009369—C8010684617172
Neoplasm metastasisD009362EFO_0009708—305592688
Pancreatic neoplasmsD010190EFO_0003860C25223011244
Liver neoplasmsD008113EFO_1001513C22.04721315
ExanthemaD005076———32128
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Squamous cell carcinoma of head and neckD000077195——7112541—19224
Non-small-cell lung carcinomaD002289——61726—2113
Squamous cell carcinomaD002294——315910—1495
Colonic neoplasmsD003110—C18304717—792
Rectal neoplasmsD012004——205212—986
CarcinomaD002277—C80.016369—957
Lung neoplasmsD008175—C34.9020283—145
Squamous cell neoplasmsD018307——13323—340
RecurrenceD012008——9234——32
AdenocarcinomaD000230——9205—129
Show 29 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C501512——125
Pancreatic ductal carcinomaD021441——134———13
Salivary gland neoplasmsD012468EFO_0003826D1177———12
Verrucous carcinomaD018289——75——111
GlioblastomaD005909EFO_0000515—76———9
Ovarian neoplasmsD010051EFO_0003893C5665———9
Uterine cervical neoplasmsD002583——37———9
CholangiocarcinomaD018281—C22.126———8
SarcomaD012509——44———7
Anus neoplasmsD001005EFO_0003835C2124———6
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545——5———16
Kidney neoplasmsD007680EFO_0003865C643————3
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A1———12
Small cell carcinomaD018288——1———12
Neurofibromatosis 1D009456—Q85.011————1
Transitional cell carcinomaD002295——1————1
Respiratory tract neoplasmsD012142EFO_0003853D141————1
Castleman diseaseD005871EFO_1001332D47.Z21————1
Soft tissue neoplasmsD012983——1————1
Neurofibromatosis 2D016518—Q85.021————1
Show 17 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypersensitivityD006967EFO_0003785T78.40————22
PainD010146EFO_0003843R52————22
Chronic periodontitisD055113EFO_0006343K05.3————22
PeriodontitisD010518EFO_0000649K05.3————22
Body weightD001835EFO_0004338—————11
Weight lossD015431——————11
PrognosisD011379——————11
Deglutition disordersD003680—R13.1————11
HypoxiaD000860—R09.02————11
Mass spectrometryD013058——————11
Show 3 more
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)Loading
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-ID—
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Erbitux – Eli Lilly
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Erbitux – Bristol Myers Squibb
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Erbitux
Adverse Events
Top Adverse Reactions
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35,131 adverse events reported
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