Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.