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Title | Erbitux (cetuximab) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125084 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Cetuximab | Erbitux | IMC-C225 | EGFR Antibody 60 | 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 |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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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... |
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 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 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 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 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... |