Ojemda (tovorafenib) is a weekly oral drug that blocks RAF kinases involved in tumor growth in children with pediatric low-grade glioma (pLGG) with certain changes in the BRAF gene, such as a fusion, rearrangement, or V600 mutation[1][3]. The European Medicines Agency (EMA) has recommended conditional marketing authorization for patients aged 6 months and older whose disease has worsened despite previous treatment with one or more systemic medicinal products[3]. The US approval in April 2024 was accelerated based on the results of the phase 2 FIREFLY-1 study, where the drug achieved a response in patients with relapsed or refractory pLGG with BRAF alterations[1][2][5]. The study included 76 patients with radiographic progression and a measurable lesion, with a dose of 290 to 476 mg/m² (max. 600 mg) per week[2][5]. The main findings include an overall response rate and a median duration of response of 13.8 months[5]. The recommended dose is 380 mg/m² orally per week (max. 600 mg), available as a tablet or suspension[2]. The EMA opinion is part of the EPAR evaluation process for human medicinal products[3].