Erbitux (cetuximab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Merck Europe B.V. Erbitux (cetuximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf. Revised July 2026. Accessed August 2, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. 1
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in combination with irinotecan-based chemotherapy. 1
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in first-line in combination with FOLFOX. 1
Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for the first line treatment. 1
Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patients who have received prior systemic therapy. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations Biomarkers Cancer types Therapies
EMA (1) BRAF p.V600E Colorectal Adenocarcinoma Cetuximab, Encorafenib
EMA (1) BRAF p.V600E Colorectal Adenocarcinoma Cetuximab, Encorafenib, Fluorouracil, Oxaliplatin
EMA (1) EGFR positive, Wild type HRAS, Wild type KRAS, Wild type NRAS Colorectal Adenocarcinoma Cetuximab
EMA (1) EGFR positive, Wild type HRAS, Wild type KRAS, Wild type NRAS Colorectal Adenocarcinoma Cetuximab, Irinotecan
EMA (1) EGFR positive, Wild type HRAS, Wild type KRAS, Wild type NRAS Colorectal Adenocarcinoma Cetuximab, Fluorouracil, Oxaliplatin