Novartis’ Tafinlar + Mekinist Receives the US FDA’s Approval for BRAF V600E Low-Grade Glioma in Pediatric Patients
- The US FDA has approved Tafinlar (dabrafenib) + Mekinist (trametinib) for pediatric patients aged ≥1yr. with LGG with a BRAF V600E mutation who requires systemic therapy. The US FDA also approved liquid formulations of Tafinlar and Mekinist
- The approval was based on the results from the P-II/III trial (TADPOLE) trial evaluating Tafinlar + Mekinist (BRAF/MEK inhibitor) vs CT in 149 children and adolescent patients
- The results showed that patients experienced an improvement in ORR of 47% vs 11% and m-PFS was 20.1 vs 7.4mos. at a median follow-up of 18.9mos. The safety profile was consistent with the known safety profile in other approved indications & the results was presented at ASCO 2022
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