The EMA has recommended a conditional marketing authorization for Ojemda (tovorafenib) in the EU for patients aged 6 months and older with pediatric low-grade glioma.[1] The drug is intended for cases of recurrent or refractory glioma with a fusion, rearrangement or V600 mutation of the BRAF gene.[1][3][4] Efficacy was evaluated in the FIREFLY-1 study (NCT04775485) in 76 patients who had received at least one prior systemic therapy.[1][3][6] The overall response rate was 51%, with tumors shrinking or disappearing completely in nearly 70% of children.[3][5][6] The median duration of response was 13.8 months.[5][6] The recommended dose is 380 mg/m² body surface area once weekly orally, to a maximum of 600 mg, with or without food, until disease progression or intolerable toxicity.[1][5][6] Tovorafenib is a type II RAF kinase inhibitor, the first approved systemic drug for this indication from 6 months of age.[4][5][7]