
Day One Biopharmaceuticals, Inc. announced that the FDA has granted approval for OJEMDA (tovorafenib), a type II RAF inhibitor, to treat patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or BRAF V600 mutation. This marks a significant advancement as OJEMDA becomes the first FDA-approved medication for children with BRAF-altered pLGG, offering once-weekly oral dosing. Approval was based on the Phase 2 FIREFLY-1 trial, showing a 51% overall response rate among evaluable patients. The company also initiated the Phase 3 FIREFLY-2/LOGGIC trial for front-line therapy. This approval addresses a critical unmet need in pediatric oncology.
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