Posted by Michael Wonder on 19 Jan 2025
US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients
17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric low-grade glioma and marks Foundation Medicine’s first companion diagnostic indication to exclusively support paediatric patients.
Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ Ojemda, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory paediatric low-grade glioma harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation.
