# Cetuximab

Cetuximab (Erbitux, Merck Europe B.V. ) has 7 EU-approved indications in 2 tumour types. 2 need a biomarker result: BRAF (2).

## Approved indications

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + encorafenib and FOLFOX | 1st line, metastatic | - |
| RAS wild-type, EGFR-expressing | + FOLFOX | 1st line, metastatic | - |
| BRAF V600E | + encorafenib | 2nd line, metastatic | After prior systemic therapy |
| RAS wild-type, EGFR-expressing | Monotherapy | 3rd line+, metastatic | Failed oxaliplatin- and irinotecan-based therapy; Intolerant to irinotecan Ambiguous in the label (line of therapy): check the SmPC. |
| RAS wild-type, EGFR-expressing | + irinotecan-based chemotherapy | Metastatic | - |

### Head and neck squamous cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + platinum-based chemotherapy | Advanced | - |
| None | + radiation therapy | Locally advanced | - |

## Products

### Erbitux

- Company: Merck Europe B.V. 
- Target: EGFR-directed monoclonal antibody
- Class: EGFR (epidermal growth factor receptor) inhibitors
- ATC: L01FE01
- EU approval: 29 Jun 2004
- Label revised: 15 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/erbitux-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux

Mechanism (SmPC section 5.1): Binds EGFR to block ligand binding, induce receptor internalisation and down-regulation, and trigger antibody-dependent cell-mediated cytotoxicity (ADCC).

## Label wording

- **Cetuximab** (Erbitux), Colorectal cancer, metastatic: “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,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 1st line, metastatic: “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,
• in first-line in combination with FOLFOX,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 3rd line+, metastatic: “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,
• in first-line in combination with FOLFOX,
• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 1st line, metastatic: “• in combination with encorafenib and FOLFOX for the first line treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Colorectal cancer, 2nd line, metastatic: “• in combination with encorafenib in patients who have received prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Head and neck squamous cell carcinoma, locally advanced: “• in combination with radiation therapy for locally advanced disease,” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)
- **Cetuximab** (Erbitux), Head and neck squamous cell carcinoma, advanced: “• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/cetuximab