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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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Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
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
1088 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
Colorectal neoplasmsD015179——3142—219
CarcinomaD002277—C80.0—82—212
Squamous cell carcinoma of head and neckD000077195———62—210
Squamous cell carcinomaD002294———42—28
Head and neck neoplasmsD006258——133——6
Squamous cell neoplasmsD018307———11—13
Microsatellite instabilityD053842————1——1
RecurrenceD012008————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8054——17
Non-small-cell lung carcinomaD002289——33———4
Nasopharyngeal neoplasmsD009303———2———2
Laryngeal neoplasmsD007822EFO_0003817C32—2———2
Stomach neoplasmsD013274EFO_0003897C16—2———2
Rectal neoplasmsD012004———2———2
Biliary tract neoplasmsD001661—C24.912———2
Esophageal neoplasmsD004938—C15—2———2
Skin neoplasmsD012878EFO_0004198C44—1———1
Mouth neoplasmsD009062EFO_0003868C06.9—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Anus neoplasmsD001005EFO_0003835C211————1
Lung neoplasmsD008175HP_0100526C34.901————1
Indications Without Phase
No data
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 46,429 documents
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Safety
Black-box Warning
Black-box warning for: Erbitux
Adverse Events
Top Adverse Reactions
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34,031 adverse events reported
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