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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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FDA approval date
EMA approval date
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Study first post date
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Completion date
Results first post 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 Application2024-07-25
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
1113 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——10225062448413
CarcinomaD002277—C80.06815430116233
Squamous cell carcinomaD002294——6513628120216
Squamous cell carcinoma of head and neckD000077195——6412236116207
Head and neck neoplasmsD006258——5311622220190
NeoplasmsD009369—C8010067726153
Neoplasm metastasisD009362EFO_0009708—114092863
Liver neoplasmsD008113EFO_1001513C22.051351527
ExanthemaD005076———41128
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——42596—290
Lung neoplasmsD008175—C34.9022477—166
RecurrenceD012008——21347——54
Rectal neoplasmsD012004——16323—853
Colonic neoplasmsD003110—C1820236—649
Squamous cell neoplasmsD018307——15373—447
AdenocarcinomaD000230——17286—244
Pancreatic neoplasmsD010190EFO_0003860C2512241—233
Esophageal neoplasmsD004938—C157263—131
Oropharyngeal neoplasmsD009959——7206—430
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C501012——120
Laryngeal diseasesD007818—J38.767——112
Verrucous carcinomaD018289——75——111
GlioblastomaD005909EFO_0000515—77———10
Salivary gland neoplasmsD012468EFO_0003826D1175———10
Tongue neoplasmsD014062EFO_0003871C02.964——110
Uterine cervical neoplasmsD002583——38———9
Paranasal sinus neoplasmsD010255——65———9
Esophageal squamous cell carcinomaD000077277——17——29
Pancreatic ductal carcinomaD021441——93———9
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thyroid neoplasmsD013964EFO_0003841—2————2
Healthy volunteers/patients———2————2
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A1———12
Small cell carcinomaD018288——1———12
Residual neoplasmD018365——2————2
Kidney neoplasmsD007680EFO_0003865C641————1
Digestive system neoplasmsD004067——1————1
Female genital neoplasmsD005833——1————1
Respiratory tract neoplasmsD012142EFO_0003853D141————1
Thoracic neoplasmsD013899——1————1
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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
Lymphatic metastasisD008207EFO_1001364—————11
Deglutition disordersD003680—R13.1————11
Mass spectrometryD013058——————11
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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 47,898 documents
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Safety
Black-box Warning
Black-box warning for: Erbitux
Adverse Events
Top Adverse Reactions
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33,954 adverse events reported
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