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 May 2022. Accessed March 12, 2024.

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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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