FDA approves dabrafenib plus trametinib for BRAF V600E low-grade glioma in children
The March 16, 2023 approval covers patients age 1 and older with low-grade glioma who require systemic therapy.
The Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for pediatric patients with low-grade glioma carrying a BRAF V600E mutation. The approval, granted March 16, 2023, covers patients 1 year of age and older whose disease requires systemic therapy.1
The FDA record also references an additional approval tied to this action, stating that the FDA also approved new oral formula1. The agency's posted record cuts off at this point, so the specifics of what the new oral formulation covers are not available from this source.
No further details on dosing, trial data, or additional regulatory actions are included in the available FDA record.
Fact check notes
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Readthrough will update this item if the agency publishes a complete version of the record or additional labeling information becomes available.
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