Therapeutic Response

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

Statements

Source and description

Braftovi (encorafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This approval was based on NCT04607421, a randomized, active-controlled, open-label, multicenter trial. Braftovi was initially evaluated in combination with cetuximab and mFOLFOX6 and later in combination with cetuximab and FOLFIRI, and the two treatment arms observed an objective response rate of 61% and 64%, respectively. The package insert states that 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.