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Tovorafenib is the first systemic therapy to be approved for the treatment of pediatric patients who have low-grade glioma with BRAF rearrangements or fusions.
Dabrafenib plus trametinib results in significantly more responses and longer progression-free survival than standard chemotherapy for pediatric patients with low-grade glioma with BRAF V600 mutations.
New approval based on TADPOLE trial showing overall response rate (ORR) of 47% and median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist compared to 11% ORR and 7.4 months mPFS
Investegate announcements from NOVARTIS AG CHF0.50(REGD), Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer
Combining dabrafenib with trametinib markedly improved response rates and delayed progression over standard-of-care chemotherapy in pediatric BRAF V600-mutant low-grade glioma in a phase 2 trial.