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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