Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Dabrafenib in patients with Melanoma.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.