# BRAF in melanoma

10 EU-approved indications in melanoma need a BRAF result: encorafenib (advanced), trametinib (advanced), trametinib (advanced), trametinib (adjuvant, locally advanced), dabrafenib (advanced), dabrafenib (advanced), dabrafenib (adjuvant, locally advanced), binimetinib (advanced), cobimetinib (advanced) and vemurafenib (advanced).

## Approved indications

### BRAF mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | + trametinib | Adjuvant, locally advanced | After complete resection; Aged 12 years and older |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | + dabrafenib | Adjuvant, locally advanced | Following complete resection; Aged 12 years and older |
| [Binimetinib](https://oncolabels.com/drugs/binimetinib) (Mektovi) | BRAF V600 | + encorafenib | Advanced | - |
| [Cobimetinib](https://oncolabels.com/drugs/cobimetinib) (Cotellic) | BRAF V600 | + vemurafenib | Advanced | - |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | + trametinib | Advanced | Aged 12 years and older |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | Monotherapy | Advanced | Aged 12 years and older |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600 | + binimetinib | Advanced | - |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | + dabrafenib | Advanced | Aged 12 years and older |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | Monotherapy | Advanced | Aged 12 years and older |
| [Vemurafenib](https://oncolabels.com/drugs/vemurafenib) (Zelboraf) | BRAF V600 | Monotherapy | Advanced | - |

## 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)
- **Trametinib** (Mekinist), Melanoma, advanced: “Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Melanoma, advanced: “Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Melanoma, adjuvant, locally advanced: “Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Melanoma, advanced: “Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Melanoma, advanced: “Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Melanoma, adjuvant, locally advanced: “Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Binimetinib** (Mektovi), Melanoma, advanced: “Binimetinib in combination with encorafenib 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/mektovi-epar-product-information_en.pdf)
- **Cobimetinib** (Cotellic), Melanoma, advanced: “Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf)
- **Vemurafenib** (Zelboraf), Melanoma, advanced: “Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zelboraf-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/melanoma/braf