Ojemda (tovorafenib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Ipsen Pharma. Ojemda (tovorafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf. Revised May 2026. Accessed August 2, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRAF rearrangements	Low-Grade Glioma, NOS	Tovorafenib
EMA (1)	v::BRAF	Low-Grade Glioma, NOS	Tovorafenib
EMA (1)	BRAF p.V600E	Low-Grade Glioma, NOS	Tovorafenib
EMA (1)	BRAF p.V600K	Low-Grade Glioma, NOS	Tovorafenib