BRAF in thyroid cancer
2 EU-approved indications in thyroid cancer need a BRAF result: trametinib (2nd line, advanced) and dabrafenib (2nd line, advanced).
Histology
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRAF mutation2 | ||||
Tafinlar | V600E | + trametinib | 2L advanced | Differentiated thyroid cancer only; After prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |
Mekinist | V600E | + dabrafenib | 2L advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |
4 approvals for Thyroid need no biomarker and apply whatever the result. All approvals for Thyroid
See also
Label wording2
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Trametinib (Mekinist)
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).
- Dabrafenib (Tafinlar)
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).