Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Tovorafenib in patients with Low-Grade Glioma, NOS.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.