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PMID
Authors
Title Erbitux (cetuximab) FDA Drug Label
Journal
Vol
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125084
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Cetuximab Cetuximab 54 42
Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 29 Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR positive colorectal cancer (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
NRAS K117X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 4, codon 117 mutations is contraindicated (FDA.gov). detail...
Unknown unknown head and neck squamous cell carcinoma not applicable Cetuximab FDA approved Actionable In a Phase III clinical trial (BONNER) that supported FDA approval, treatment with Erbitux (cetuximab) in combination with radiotherapy resulted in a median survival of 49.0 months, compared to 29.3 months with radiotherapy alone, in patients with head and neck squamous cell carinoma (PMID: 16808060; NCT00004227). 16808060 detail...
NRAS A146X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 4, codon 146 mutations is contraindicated (FDA.gov). detail...
NRAS G13X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 2, codon 13 mutations is contraindicated (FDA.gov). detail...
NRAS Q61X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 3, codon 61 mutations is contraindicated (FDA.gov). detail...
NRAS G12X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 2, codon 12 mutations is contraindicated (FDA.gov). detail...
NRAS A59X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 3, codon 59 mutations is contraindicated (FDA.gov). detail...
Unknown unknown head and neck squamous cell carcinoma not applicable Carboplatin + Cetuximab + Fluorouracil FDA approved Actionable In a Phase III clinical trial that supported FDA approval, Erbitux (cetuximab) in combination with platinum-based chemotherapy (Platinol (cisplatin) or Paraplatin (carboplatin)) and Adrucil (fluorouracil) resulted in a median overall survival of 10.1 months, versus 7.4 months with chemotherapy alone, in patients with recurrent or metastatic head and neck squamous cell carcinoma (PMID: 23576486). 23576486 detail...