Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized tovorafenib as a monotherapy for treatment of paediatric patients 6 months of age or older with low-grade glioma (LGG) harrbouring a BRAF fusion, rearrangement or V600 variant, who have progressed after one or more prior systemic therapies.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-04-20	European Medicines Agency	Indication received approval from the European Commission.