Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Trametinib in patients with Melanoma.
The European Medicines Agency (EMA) has authorized trametinib as a monotherapy or in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. Trametinib's product information further states that trametinib as a monotherapy has not demonstrated clinical activity in patients who have progressed on prior BRAF inhibitor therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.