Regulatory approval

Published by the European Medicines Agency. Approved

Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma 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
EMA (1) BRAF p.V600E Melanoma Dabrafenib
EMA (1) BRAF p.V600E Melanoma Dabrafenib, Trametinib
EMA (1) BRAF p.V600K Melanoma Dabrafenib, Trametinib
EMA (1) BRAF p.V600K Melanoma Dabrafenib