BRAF in glioma
6 EU-approved indications in glioma need a BRAF result: trametinib (any line), trametinib (any line), dabrafenib (any line), dabrafenib (any line), tovorafenib (2nd line) and tovorafenib (2nd line).
Grade
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRAF6 | ||||
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 |
One approval for Glioma needs no biomarker and applies whatever the result. All approvals for Glioma
See also
Label wording6
The sentence from section 4.1 of the SmPC that each indication above comes from.
- 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 (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).