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 March 2024. Accessed March 23, 2024.

Regulatory approvals

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

Indication	Statements
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	4
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.	2
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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Dabrafenib
Sensitivity (+)	BRAF p.V600E	Melanoma	Dabrafenib, Trametinib
Sensitivity (+)	BRAF p.V600K	Melanoma	Dabrafenib, Trametinib
Sensitivity (+)	BRAF p.V600K	Melanoma	Dabrafenib
Sensitivity (+)	BRAF p.V600E	Melanoma	Dabrafenib, Trametinib
Sensitivity (+)	BRAF p.V600K	Melanoma	Dabrafenib, Trametinib
Sensitivity (+)	BRAF p.V600E	Non-Small Cell Lung Cancer	Dabrafenib, Trametinib
Sensitivity (+)	BRAF p.V600K	Non-Small Cell Lung Cancer	Dabrafenib, Trametinib