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Breakthrough Approval: FDA Greenlights Tovorafenib for BRAF-Altered Pediatric Low-Grade Glioma

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Emedinexus    25 May 2025

The FDA has granted accelerated approval to tovorafenib (Ojemda) for the treatment of patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) that harbors a BRAF fusion or rearrangement, or a BRAF V600 mutation. This approval marks a significant advancement in the treatment of pediatric LGG, a condition often resistant to standard therapies. The drug, developed by Day One Biopharmaceuticals, Inc., shows promising efficacy in targeting these specific genetic alterations, providing a new option for children with this challenging form of glioma.

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