Regulatory approval

Published by the European Medicines Agency.

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 May 2022. Accessed March 12, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR positive, Wild type HRAS, Wild type KRAS, Wild type NRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Oxaliplatin