Novartis: FDA approves cancer drug
(CercleFinance.com) - Novartis today announced that the US FDA has approved Tafinlar (dabrafenib) + Mekinist (trametinib) for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer.
This new approval is based on the TADPOLE trial showing an overall response rate (ORR) of 47% and a median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist, compared to 11% ORR and 7.4 months mPFS for standard therapy.
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.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
This new approval is based on the TADPOLE trial showing an overall response rate (ORR) of 47% and a median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist, compared to 11% ORR and 7.4 months mPFS for standard therapy.
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.
Copyright (c) 2023 CercleFinance.com. All rights reserved.