Article
FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma.
Clinical cancer research : an official journal of the American Association for Cancer Research - 17 Jan 2024
Barbato Michael I, Nashed Jeannette, Bradford Diana, Ren Yi, Khasar Sachia, Miller Claudia P, Zolnik Banu S, Zhao Hong, Li Yangbing, Bi Youwei, Shord Stacy S, Amatya Anup K, Mishra-Kalyani Pallavi S, Scepura Barbara, Al-Matari Raniya A, Pazdur Richard, Kluetz Paul G, Donoghue Martha, Singh Harpreet, Drezner Nicole
Abstract excerpt
On March 16, 2023, the FDA approved dabrafenib in combination with trametinib (Tafinlar, Mekinist; Novartis Pharmaceuticals Corporation) for the treatment of pediatric patients with low-grade glioma (LGG) with a BRAFV600E mutation who require systemic therapy. FDA also approved oral formulations of both drugs suitable for patients who cannot swallow pills. This approval was based on the LGG cohort from study...
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