Posted by Michael Wonder on 23 Apr 2026
Ojemda approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration
22 April 2026 - Approval is based on pivotal Phase 2 FIREFLY-1 data demonstrating meaningful and durable tumour responses.
Ipsen today announced that the European Commission has granted conditional marketing authorisation for Ojemda (tovorafenib) as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
