Posted by Michael Wonder on 23 Apr 2024
FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF altered paediatric low-grade glioma
23 April 2024 - Today, the FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals) for patients 6 months of age and older with relapsed or refractory paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation.
This represents the first FDA approval of a systemic therapy for the treatment of patients with paediatric LGG with BRAF rearrangements, including fusions.
