# Encorafenib

Encorafenib (Braftovi, Pierre Fabre Medicament) has 4 EU-approved indications in 3 tumour types. Each needs a biomarker result: BRAF (4).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + binimetinib | Advanced | - |

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + cetuximab and FOLFOX | 1st line, metastatic | - |
| BRAF V600E | + cetuximab | 2nd line, metastatic | After prior systemic therapy |

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600 | + binimetinib | Advanced | - |

## Products

### Braftovi

- Company: Pierre Fabre Medicament
- Target: BRAF inhibitor
- Class: B-raf serine-threonine kinase (BRAF) inhibitors
- ATC: L01EC03
- EU approval: 19 Sep 2018
- Label revised: 1 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/braftovi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi

Mechanism (SmPC section 5.1): ATP-competitive RAF kinase inhibitor (BRAF V600E, BRAF, CRAF) that suppresses RAF/MEK/ERK signalling and growth of BRAF V600-mutant tumour cells; it does not inhibit signalling in wild-type BRAF cells.

## Label wording

- **Encorafenib** (Braftovi), Melanoma, advanced: “Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf)
- **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)
- **Encorafenib** (Braftovi), Non-small cell lung cancer, advanced: “Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-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/encorafenib