# BRAF in thyroid cancer

2 EU-approved indications in thyroid cancer need a BRAF result: trametinib (2nd line, advanced) and dabrafenib (2nd line, advanced).

## Approved indications

### BRAF mutation

| 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

- **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)
- **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)

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/thyroid-cancer/braf
