# BRAF in glioma

6 EU-approved indications in glioma need a BRAF result: trametinib (any line), trametinib (any line), dabrafenib (any line), dabrafenib (any line), tovorafenib (2nd line) and tovorafenib (2nd line).

## Approved indications

### BRAF

| 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 |

## Label wording

- **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** (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)

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/glioma/braf