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PMID
Authors
Title Erbitux (cetuximab) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125084
Abstract Text

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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 51 63
Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 72 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, and in combination with Braftovi (encorafenib) with or without mFOLFOX6 in patients with metastatic colorectal cancer with BRAF V600E (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...
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib + Fluorouracil + Leucovorin + Oxaliplatin FDA approved - On Companion Diagnostic Actionable In a Phase III trial (BREAKWATER) that supported FDA approval, Braftovi (encorafenib) in combination with Erbitux (cetuximab) and mFOLFOX6 significantly improved objective response rate (60.9%, 67/110 vs 40.0%, 44/110, OR 2.443, p=0.0008) compared to standard of care in patients with metastatic colorectal cancer harboring BRAF V600E, with median duration of response of 13.9 vs 11.1 mo, and overall survival was not estimable vs 14.6 mo (HR 0.47) (PMID: 39863775; NCT04607421). detail... 39863775 detail... 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 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 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...
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...