# BRAF in colorectal cancer

4 EU-approved indications in colorectal cancer need a BRAF result: encorafenib (2nd line, metastatic), encorafenib (1st line, metastatic), cetuximab (1st line, metastatic) and cetuximab (2nd line, metastatic).

## Approved indications

### BRAF mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | BRAF V600E | + encorafenib and FOLFOX | 1st line, metastatic | - |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600E | + cetuximab and FOLFOX | 1st line, metastatic | - |
| [Cetuximab](https://oncolabels.com/drugs/cetuximab) (Erbitux) | BRAF V600E | + encorafenib | 2nd line, metastatic | After prior systemic therapy |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600E | + cetuximab | 2nd line, metastatic | After prior systemic therapy |

## Label wording

- **Encorafenib** (Braftovi), Colorectal cancer, 2nd line, metastatic: “Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf)
- **Encorafenib** (Braftovi), Colorectal cancer, 1st line, metastatic: “Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-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)

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/tumours/colorectal-cancer/braf