Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized trametinib in combination with dabrafenib for the treatment of pediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF p.V600E variant who require systemic therapy.

This is written in the approval document as:

Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

Citation

Novartis Europharm Limited. Spexotras (trametinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf. Revised January 2024. Accessed March 28, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRAF p.V600E	Low-Grade Glioma	Dabrafenib, Trametinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2024-01-05	European Medicines Agency	Indication received approval from the European Commission.