Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized cetuximab in combination with FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) for the first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR positive, Wild type HRAS, Wild type KRAS, Wild type NRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Oxaliplatin

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2012-01-13	European Medicines Agency	Indication received approval from the European Commission.