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FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

March 20, 2023 9:50 AM | Katy Monaco (Administrator)

Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills. This represents the first FDA approval of a systemic therapy for the first-line treatment of pediatric patients with LGG with a BRAF V600E mutation. View full prescribing information for Tafinlar and MekinistRead More



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