# BRAF 26 EU-approved indications of 8 drugs need a BRAF result, in 5 tumour types, most of them in melanoma, glioma and colorectal cancer. ## Approved indications by tumour ### Non-small cell lung cancer | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Binimetinib](https://oncolabels.com/drugs/binimetinib) (Mektovi) | BRAF V600E | + encorafenib | Advanced | - | | [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | + trametinib | Advanced | - | | [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600E | + binimetinib | Advanced | - | | [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | + dabrafenib | Advanced | - | ### Colorectal cancer | 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 | ### Melanoma | 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 | - | ### Glioma | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Tovorafenib](https://oncolabels.com/drugs/tovorafenib) (Ojemda) | BRAF fusion | Monotherapy | 2nd line | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older | | [Tovorafenib](https://oncolabels.com/drugs/tovorafenib) (Ojemda) | BRAF V600 | Monotherapy | 2nd line | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older | | [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Finlee) | BRAF V600E | + trametinib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy | | [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Finlee) | BRAF V600E | + trametinib | Any line | High-grade glioma only; Children and adolescents only; After at least one prior radiation and/or chemotherapy treatment; Aged 1 year and older | | [Trametinib](https://oncolabels.com/drugs/trametinib) (Spexotras) | BRAF V600E | + dabrafenib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy | | [Trametinib](https://oncolabels.com/drugs/trametinib) (Spexotras) | BRAF V600E | + dabrafenib | Any line | High-grade glioma only; Children and adolescents only; After at least one prior radiation and/or chemotherapy treatment; Aged 1 year and older | ### Thyroid cancer | Drug | Biomarker requirement | Regimen | Setting | Conditions | |---|---|---|---|---| | [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600E | + trametinib | 2nd line, advanced | Differentiated thyroid cancer only; After prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) | | [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600E | + dabrafenib | 2nd line, advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) | ## 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) - **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) - **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) - **Trametinib** (Mekinist), Non-small cell lung cancer, advanced: “Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf) - **Trametinib** (Mekinist), Thyroid cancer, 2nd line, advanced: “Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf) - **Trametinib** (Spexotras), Glioma, any line: “Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf) - **Trametinib** (Spexotras), Glioma, any line: “Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/spexotras-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) - **Dabrafenib** (Tafinlar), Non-small cell lung cancer, advanced: “Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf) - **Dabrafenib** (Tafinlar), Thyroid cancer, 2nd line, advanced: “Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf) - **Dabrafenib** (Finlee), Glioma, any line: “Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf) - **Dabrafenib** (Finlee), Glioma, any line: “Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf) - **Tovorafenib** (Ojemda), Glioma, 2nd line: “Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf) - **Tovorafenib** (Ojemda), Glioma, 2nd line: “Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ojemda-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) - **Binimetinib** (Mektovi), Non-small cell lung cancer, advanced: “Binimetinib in combination with encorafenib 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/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/biomarkers/braf