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 as a monotherapy or in combination with trametinib for the treatment of adult and adolescent patients aged 12 years and older 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 adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation.