FDA Approves Novartis' Tafinlar + Mekinist For Pediatric Brain Cancer With Certain Mutations

The FDA has approved Novartis AG's NVS Tafinlar (dabrafenib) + Mekinist (trametinib) for pediatric patients one year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
LGG is the most common pediatric brain cancer. BRAF V600 mutations are present in 15-20% of pediatric LGGs.
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.
These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.
Also Read: Novartis' Prostate Cancer Therapy Hit By Supply Crunch, Seeks To Ramp Up Production To Ease Supply Issues.
The FDA approval is based on results from the Phase 2/3 TADPOLE trial. Patients randomized to receive Tafinlar + Mekinist experienced a statistically significant improvement in overall response rate (ORR) of 47% compared to 11% for those randomized to receive chemotherapy.
At a median follow-up of 18.9 months, median progression-free survival (PFS) was 20.1 months with Tafinlar + Mekinist compared to 7.4 months with chemotherapy.
This FDA approval is the sixth for Tafinlar + Mekinist, which is indicated across multiple BRAF V600 solid tumors, including melanoma, thyroid, and lung cancer.
Price Action: NVS shares are up 0.57% at $83.25 during the premarket session on the last check Friday.
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