Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Dabrafenib, Trametinib in patients with High-Grade Glioma, NOS.
The European Medicines Agency (EMA) has authorized trametinib in combination with dabrafenib for the treatment of pediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF p.V600E variant who have received at least one prior radiation and/or chemotherapy treatment.
This statement is based on a regulatory approval from the European Medicines Agency:
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.