2023-03-19| Trials & Approvals

Novartis Snags Pediatric Brain Cancer Indication for Oncology Combination Therapy

by Reed Slater
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In its sixth approval indication, the FDA gave the nod to Novartis’ Tafinlar and Mekinist combination therapy to treat pediatric patients with BRAF V600E low-grade glioma, the most common brain cancer in pediatric patients. The most recent approval marks the first and only combination therapy approved to treat children as young as one-year-old with BRAF V600E low-grade glioma.

A First-Line Treatment for a Devastating Disease

Low-grade glioma (LGG) is the most common pediatric brain cancer, and the BRAF V600E mutation is a known driver of cancer growth. Unfortunately, regardless of the type of solid tumor, there are limited treatment options for patients with the BRAF V600E mutation. 

Novartis’ Tafinlar and Mekinist combination therapy is a potential solution for the many children with BRAF V600E LGG. Approved in various oral forms to accommodate those who cannot swallow pills, the FDA approved the combination as a first-line therapy to treat the disease. 

Reshema Kemps-Polanco, Executive Vice President of U.S. Oncology at Novartis, said, “This new indication for Tafinlar + 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.”

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Clinical Trial Results Supporting the Approval

The FDA approved Tafinlar and Mekinist based on the TADPOLE trial, which included 149 participants with BRAF V600E LGG. The randomized trial compared the safety and efficacy of the combination therapy with standard chemotherapy.

Of the participants who received Tafinlar and Mekinist, 47% achieved an overall response rate compared to only 11% who received chemotherapy. Additionally, the progression-free survival for those who took the combination therapy was 20.1 months compared to 7.4 months for those in the chemotherapy arm. 

As with most oncology drugs, Tafinlar and Mekinist can elicit some adverse events, the most common being fever, rash, headache, and vomiting. The FDA deemed the safety profile more advantageous than harmful, given the therapy’s efficacy. 

With six indications under its belt, Novartis’ Tafinlar and Mekinist combination therapy is making waves in the oncology market. The most recent indication to treat BRAF V600E LGG is a big step forward for the combination and a big step forward for therapies designed to treat brain cancers in young children. 

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