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 |
|---|---|
| neoplasms | D009369 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Erbitux
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| erbitux | Biologic Licensing Application | 2023-06-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| squamous cell carcinoma | — | D002294 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
cetuximab, Erbitux, Eli Lilly and Company | |||
| 2113-03-01 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9055 | Injection, cetuximab, 10 mg |
Clinical
Clinical Trials
1037 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 neoplasms | D015179 | — | — | 79 | 207 | 52 | 3 | 39 | 337 |
| Head and neck neoplasms | D006258 | — | — | 38 | 92 | 15 | 2 | 14 | 146 |
| Neoplasms | D009369 | — | C80 | 65 | 40 | 3 | 1 | 4 | 94 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 4 | 10 | 3 | 2 | — | 16 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 4 | 1 | 1 | — | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 51 | 78 | 22 | — | 10 | 138 |
| Non-small-cell lung carcinoma | D002289 | — | — | 25 | 45 | 5 | — | 1 | 63 |
| Squamous cell carcinoma | D002294 | — | — | 16 | 30 | 4 | — | 5 | 42 |
| Colonic neoplasms | D003110 | — | C18 | 19 | 19 | 3 | — | 5 | 41 |
| Rectal neoplasms | D012004 | — | — | 14 | 24 | 1 | — | 3 | 37 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 12 | 23 | 1 | — | 2 | 32 |
| Squamous cell neoplasms | D018307 | — | — | 10 | 27 | 2 | — | 2 | 31 |
| Esophageal neoplasms | D004938 | — | C15 | 6 | 23 | 3 | — | — | 26 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 5 | 17 | 1 | — | 1 | 23 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 17 | 1 | — | — | 20 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 9 | 11 | — | — | — | 18 |
| Verrucous carcinoma | D018289 | — | — | 7 | 5 | — | — | 1 | 11 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 7 | 5 | — | — | — | 10 |
| Tongue neoplasms | D014062 | EFO_0003871 | C02.9 | 6 | 4 | — | — | 1 | 10 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 3 | 8 | — | — | — | 9 |
| Glioblastoma | D005909 | EFO_0000515 | — | 6 | 5 | — | — | — | 8 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 5 | 6 | — | — | 1 | 8 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 6 | — | — | — | 7 |
| Cholangiocarcinoma | D018281 | — | C22.1 | — | 6 | — | — | — | 6 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | 3 | — | — | 1 | 5 |
Show 54 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 3 | — | — | — | 1 | 4 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Small cell carcinoma | D018288 | — | — | 1 | — | — | — | 1 | 2 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 1 | — | — | — | — | 1 |
| Respiratory tract neoplasms | D012142 | EFO_0003853 | D14 | 1 | — | — | — | — | 1 |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | 1 | — | — | — | — | 1 |
| Soft tissue neoplasms | D012983 | — | — | 1 | — | — | — | — | 1 |
| Neurofibromatosis 2 | D016518 | — | Q85.02 | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 1 | 1 |
| Prognosis | D011379 | — | — | — | — | — | — | 1 | 1 |
| Lymphatic metastasis | D008207 | EFO_1001364 | — | — | — | — | — | 1 | 1 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | — | — | — | 1 | 1 |
| Mass spectrometry | D013058 | — | — | — | — | — | — | 1 | 1 |
| Drug resistance | D004351 | — | Z16.30 | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 1 | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cetuximab |
| INN | cetuximab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| 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
| PDB | 1YY8, 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 ID | CHEMBL1201577 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00002 |
| UNII ID | PQX0D8J21J (ChemIDplus, GSRS) |
Target
Agency Approved
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
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
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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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 43,472 documents
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Safety
Black-box Warning
Black-box warning for: Erbitux
Adverse Events
Top Adverse Reactions
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29,735 adverse events reported
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