Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Dabrafenib, Trametinib in patients with Melanoma.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.