Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Cetuximab, Encorafenib in patients with Colorectal Adenocarcinoma.
The European Medicines Agency (EMA) has authorized encorafenib in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF p.V600E variant, who have received prior systemic therapy. The efficacy and safety of encorafenib have been established only in patients with melanoma tumours expressing BRAF V600E and V600K variants or colorectal tumours expressing BRAF V600E.
This statement is based on a regulatory approval from the European Medicines Agency:
Encorafenib is indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.