Novartis : FDA Approves Tafinlar Combination For Pediatric Brain Cancer Treatment

Novartis (NVS) said that the U.S. Food and Drug Administration approved combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.

Low-grade glioma (LGG) is the most common pediatric brain cancer. BRAF V600 mutations are present in 15-20% of pediatric LGGs and are associated with poor survival outcomes and less favorable response to chemotherapy.

The new approval was 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 for standard of care.

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.

The approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG, the company said.

Tafinlar + Mekinist is now approved in six indications across multiple BRAF V600E solid tumors, including melanoma, thyroid cancer and lung cancer.

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