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Novartis: FDA approves cancer drug

( - Novartis today announced that the US FDA has approved Tafinlar (dabrafenib) + Mekinist (trametinib) for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer.

This new approval is based on the TADPOLE trial showing an overall response rate (ORR) of 47% and a median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist, compared to 11% ORR and 7.4 months mPFS for standard therapy.

The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.

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