Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized dabrafenib in combination with trametinib for the adjuvant treatment of adult patients with stage 3 melanoma with a BRAF V600 variant, following complete resection.

This is written in the approval document as:

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.

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.

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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, Trametinib
EMA (1) BRAF p.V600K Melanoma Dabrafenib, Trametinib