# Tovorafenib

Tovorafenib (Ojemda, Ipsen Pharma) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: BRAF (2).

## Approved indications

### Glioma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF fusion | Monotherapy | 2nd line | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older |
| BRAF V600 | Monotherapy | 2nd line | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older |

## Products

### Ojemda

- Company: Ipsen Pharma
- Target: Type II RAF kinase inhibitor
- Class: B-raf serine-threonine kinase (BRAF) inhibitors
- ATC: L01EC04
- EU approval: 20 Apr 2026
- Label revised: 11 May 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ojemda-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ojemda

Mechanism (SmPC section 5.1): CNS-penetrant Type II RAF inhibitor of mutant BRAF V600E, wild-type BRAF and CRAF (monomers, dimers and BRAF fusions), suppressing MAPK pathway activation.

## Label wording

- **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/drugs/tovorafenib