Therapeutic Response

v::BRAF status confers therapeutic sensitivity to Tovorafenib in patients with Low-Grade Glioma.

Statements

Source and description
Ojemda (tovorafenib) [package insert]. FDA. 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).
Ojemda (tovorafenib) [product information]. EMA. 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.