Tafinlar (dabrafenib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
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.	4
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRAF p.V600E	Melanoma	Dabrafenib
EMA (2)	BRAF p.V600E	Melanoma	Dabrafenib, Trametinib
EMA (2)	BRAF p.V600K	Melanoma	Dabrafenib, Trametinib
EMA (1)	BRAF p.V600E	Non-Small Cell Lung Cancer	Dabrafenib, Trametinib
EMA (1)	BRAF p.V600K	Non-Small Cell Lung Cancer	Dabrafenib, Trametinib
EMA (1)	BRAF p.V600K	Melanoma	Dabrafenib