(News Bulletin 247) – Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for pediatric patients with glioma of low-grade BRAF V600E, 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 of mPFS for standard treatment.
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 old.
“These approvals make Tafinlar + Mekinist the first and only combination targeted therapy approved to treat pediatric patients with BRAF V600E LGG,” the group says.
‘The development of targeted therapies based on the unique genetic characteristics of a patient’s tumor is the future of pediatric cancer care.’ said Dr. Eric Bouffet, MD, FRCPC, principal investigator of the TADPOLE clinical trial and associate scientist emeritus at the Hospital for Sick Children (SickKids).
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