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

Approved indications, Thyroid cancer
DrugBiomarker requirementRegimenSettingConditions
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.

  1. 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).
  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).