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 U.S. Food and Drug Administration granted approval to cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
This statement is based on a regulatory approval from the Food and Drug Administration:
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.