Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Tovorafenib in patients with Low-Grade Glioma, NOS.
The U.S. Food and Drug Administration granted accelerated approval to tovorafenib for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The product label states that this indication is approved under accelerated approval based on response rate and duration of response and furthermore that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
This statement is based on a regulatory approval from the Food and Drug Administration:
OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.