Dabrafenib with Trametinib Has Been FDA-Approved for LGG with a BRAF V600E Mutation

On March 16th, 2023, the US FDA approved dabrafenib (Tafinlar), with trametinib (Mekinist) for pediatric patients aged 1 year and older with Low-Grade Glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The agency also approved new oral formulations of both medicines suitable for those who can not swallow pills.

This is the first approval by the FDA of a systemic therapy for the first-line treatment of pediatric patients with Low-Grade Glioma with a BRAF V600E mutation.

The efficacy was assessed in a multicenter, open-label trial CDRB436G2201 (NCT02684058) in those with Low-Grade Glioma (WHO grades 1 & 2) requiring first systemic therapy. Patients were randomized 2:1 to medicine dabrafenib along with trametinib (D+T) or medication carboplatin along with vincristine (C+V).

The proposed doses for drugs dabrafenib plus trametinib in pediatric patients depend on body weight; dabrafenib is given by mouth twice daily and trametinib is given by mouth once daily. Treatment is given until disease progression or unacceptable adverse reactions.

About Pediatric Low-Grade Gliomas (LGG):

Pediatric LGGs are a group of stilly-growing tumors that can develop in several sites throughout the brain and spinal cord. They are typically CNS tumors in children and adolescents. LGG is classified as pilocytic astrocytoma, pilomyxoid astrocytoma, and ganglioglioma.

Pediatric Low-Grade Gliomas rarely progressed beyond their place of origin and are known as benign as most can be cured with the help of surgical elimination if this is feasible.

However, Low-Grade Gliomas (LGG) may develop in locations in the brain such as the vision tracts where surgery is not an option. At this juncture, multiple courses of therapies, including chemo or radiation can be recommended to prevent the progression of the tumor.

Reference:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dabrafenib-trametinib-pediatric-patients-low-grade-glioma-braf-v600e-mutation#:~:text=On%20March%2016%2C%202023%2C%20the,mutation%20who%20require%20systemic%20therapy.