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FDA Approves Novartis Treatment Combination for Pediatric Glioma
Drugs Submissions and Approvals
The FDA has granted expanded approval to Novartis’ Tafinlar (dabrafenib) in combination with Novartis’ Mekinist (trametinib) for pediatric patients one year and older with low-grade glioma with a BRAF V600E mutation and who require systemic therapy.
The agency also approved new oral formulations of both drugs for patients who cannot swallow pills.
The FDA decision was supported by results from a study that demonstrated an overall response rate of 46.6 percent and a progression-free survival of 20.1 months. In the interim analysis, however, overall survival did not reach statistical significance.
This is the first systemic therapy approved for first-line treatment in this patient population.