Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized dabrafenib as a monotherapy or in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant.

This is written in the approval document as:

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.

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.

Therapeutic response

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

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
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