Regulatory approval

Published by the European Medicines Agency. Approved

Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

This is written in the approval document.

Citation

Novartis Europharm Limited. Tafinlar (dabrafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf. Revised May 2026. Accessed August 2, 2026.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
EMA (1) BRAF p.V600E Non-Small Cell Lung Cancer Dabrafenib, Trametinib
EMA (1) BRAF p.V600K Non-Small Cell Lung Cancer Dabrafenib, Trametinib

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2017-03-29 European Medicines Agency Indication received approval from the European Commission.