BRAF in melanoma
10 EU-approved indications in melanoma need a BRAF result: encorafenib (advanced), trametinib (advanced), trametinib (advanced), trametinib (adjuvant, locally advanced), dabrafenib (advanced), dabrafenib (advanced), dabrafenib (adjuvant, locally advanced), binimetinib (advanced), cobimetinib (advanced) and vemurafenib (advanced).
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRAF mutation10 | ||||
Tafinlar | V600 | + trametinib | Adj. locally adv. | After complete resection; Aged 12 years and older |
Mekinist | V600 | + dabrafenib | Adj. locally adv. | Following complete resection; Aged 12 years and older |
Mektovi | V600 | + encorafenib | Any line advanced | None |
Cotellic | V600 | + vemurafenib | Any line advanced | None |
Tafinlar | V600 | + trametinib | Any line advanced | Aged 12 years and older |
Tafinlar | V600 | Monotherapy | Any line advanced | Aged 12 years and older |
Braftovi | V600 | + binimetinib | Any line advanced | None |
Mekinist | V600 | + dabrafenib | Any line advanced | Aged 12 years and older |
Mekinist | V600 | Monotherapy | Any line advanced | Aged 12 years and older |
Zelboraf | V600 | Monotherapy | Any line advanced | None |
8 approvals for Melanoma need no biomarker and apply whatever the result. All approvals for Melanoma
See also
Label wording10
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Encorafenib (Braftovi)
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
- Trametinib (Mekinist)
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).
- Trametinib (Mekinist)
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).
- Trametinib (Mekinist)
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.
- Dabrafenib (Tafinlar)
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).
- Dabrafenib (Tafinlar)
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).
- Dabrafenib (Tafinlar)
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.
- Binimetinib (Mektovi)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
- Cobimetinib (Cotellic)
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).
- Vemurafenib (Zelboraf)
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).