Approvals

The FDA has approved Novartis’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of BRAF V600E low-grade glioma (LGG) in paediatric patients over the age of one.

Liquid formulations of the drugs have also been approved to make administration easier across various approved indications.

This is not only the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for paediatric patients as young as one year, but it also makes Tafinlar and Mekinist the only approved combination therapy for BRAF V600E LGG in paediatric patients.

This is the sixth approval for the combination, which is also approved for several BRAF V600 solid tumours, such as lung cancer, melanoma and thyroid cancer.

Reshema Kemps-Polanco, Novartis Oncology US’s executive vice-president, commented: “This new indication for Tafinlar and Mekinist is a potential new standard-of-care treatment option for young patients with this form of brain cancer with a BRAF V600E mutation, in formulations specifically designed for them. We are thankful for the families, including children and adolescents, that participated in the clinical trial that led to this approval and whose bravery has led to a new hope for children living with this serious brain cancer.”

This approval follows positive results from the phase 2/3 TADPOLE clinical trial, which showed a significant improvement in overall response rate in patients treated with the combination therapy, when compared to a placebo group.

DrRogerPacker,seniorvicepresidentoftheCenterfor Neurosciences and Behavioral Medicine at Children’s National Hospital, added: “It is more important than ever to test for genetic mutations in patients living with low-grade glioma. This FDA approval may offer new hope to paediatric patients living with BRAF V600E low-grade glioma. This has the potential to change the way healthcare providers treat these paediatric patients, offering a significant advancement compared to chemotherapy.”