Therapeutic Response

BRAF p.V600E status confers therapeutic sensitivity to Cetuximab in combination with Encorafenib in patients with Colorectal Adenocarcinoma.

Statements

Source and description
Braftovi (encorafenib) [product information]. EMA. 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.
Braftovi (encorafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to encorafenib in combination with cetuximab 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. Encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.
Erbitux (cetuximab) [package insert]. FDA. 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.