BRAF
26 EU-approved indications of 8 drugs need a BRAF result, in 5 tumour types, most of them in melanoma, glioma and colorectal cancer.
Approved indications26
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Non-small cell lung cancer4 | ||||
Mektovi | V600E | + encorafenib | Any line advanced | None |
Tafinlar | V600 | + trametinib | Any line advanced | None |
Braftovi | V600E | + binimetinib | Any line advanced | None |
Mekinist | V600 | + dabrafenib | Any line advanced | None |
| Colorectal cancer4 | ||||
Erbitux | V600E | + encorafenib and FOLFOX | 1L metastatic | None |
Braftovi | V600E | + cetuximab and FOLFOX | 1L metastatic | None |
Erbitux | V600E | + encorafenib | 2L metastatic | After prior systemic therapy |
Braftovi | V600E | + cetuximab | 2L metastatic | After prior systemic therapy |
| Melanoma10 | ||||
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 |
| Glioma6 | ||||
Ojemdaconditional | Monotherapy | 2L | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older | |
Ojemdaconditional | V600 | Monotherapy | 2L | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older |
Finlee | V600E | + trametinib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
Finlee | 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 |
Spexotras | V600E | + dabrafenib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
Spexotras | 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 |
| Thyroid cancer2 | ||||
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) |
BRAF by tumour
Label wording26
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.
- Encorafenib (Braftovi)
Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.
- Encorafenib (Braftovi)
Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.
- Encorafenib (Braftovi)
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
- Cetuximab (Erbitux)
• in combination with encorafenib and FOLFOX for the first line treatment.
- Cetuximab (Erbitux)
• in combination with encorafenib in patients who have received prior systemic therapy.
- 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.
- Trametinib (Mekinist)
Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.
- 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).
- Trametinib (Spexotras)
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.
- Trametinib (Spexotras)
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.
- 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.
- Dabrafenib (Tafinlar)
Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.
- 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).
- Dabrafenib (Finlee)
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.
- Dabrafenib (Finlee)
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.
- Tovorafenib (Ojemda)
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).
- Tovorafenib (Ojemda)
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).
- 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.
- Binimetinib (Mektovi)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E 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).