FDA Grants Accelerated Approval for Ojemda for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
The FDA has provided accelerated approval to Day One Biopharmaceuticals, Inc. for Ojemda (tovorafenib), a type II RAF inhibitor.
- pLGG is the most common brain tumor diagnosed in children, with patients suffering profound tumorand treatment-associated morbidities that can impact their life trajectory. With this approval, Day One Biopharmaceuticals has received a rare pediatric disease priority review voucher from the FDA. Until now, there had been no medicines approved for patients with pLGG driven by BRAF fusions. Ojemda is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
- BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration. Ojemda is the only systemic therapy for pLGG that offers once-weekly dosing, with or without food, as a tablet or oral suspension.
Source: Day One Biopharmaceuticals, Inc.
