# Glioma

The EU has approved 9 indications of 5 drugs in glioma. 8 of them need a biomarker result: BRAF (6) and IDH1/2 (2). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### BRAF

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Tovorafenib](https://oncolabels.com/drugs/tovorafenib) (Ojemda) | BRAF fusion | Monotherapy | 2nd line | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older |
| [Tovorafenib](https://oncolabels.com/drugs/tovorafenib) (Ojemda) | BRAF V600 | Monotherapy | 2nd line | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Finlee) | BRAF V600E | + trametinib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Finlee) | BRAF 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 |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Spexotras) | BRAF V600E | + dabrafenib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Spexotras) | BRAF 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 |

### IDH1/2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Vorasidenib](https://oncolabels.com/drugs/vorasidenib) (Voranigo) | IDH1 R132 or IDH2 R172 | Monotherapy | 1st line | Grade 2 only; After surgical intervention only; Aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy Ambiguous in the label (requirement): check the SmPC. |
| [Vorasidenib](https://oncolabels.com/drugs/vorasidenib) (Voranigo) | IDH2 R172 | Monotherapy | Any line | Grade 2 only; After surgical intervention only; Aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Everolimus](https://oncolabels.com/drugs/everolimus) (Votubia) | None | Monotherapy | Any line | SEGA with tuberous sclerosis only; Tuberous sclerosis complex; require therapeutic intervention but are not amenable to surgery |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Everolimus** (Votubia), Glioma, any line: “Votubia is indicated for the treatment of adult and paediatric patients with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/votubia-epar-product-information_en.pdf)
- **Vorasidenib** (Voranigo), Glioma, 1st line: “Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf)
- **Vorasidenib** (Voranigo), Glioma, any line: “Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf)
- **Trametinib** (Spexotras), Glioma, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf)
- **Trametinib** (Spexotras), Glioma, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf)
- **Dabrafenib** (Finlee), Glioma, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf)
- **Dabrafenib** (Finlee), Glioma, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf)
- **Tovorafenib** (Ojemda), Glioma, 2nd line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf)
- **Tovorafenib** (Ojemda), Glioma, 2nd line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/glioma