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.

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