Therapeutic Response

BRAF p.V600E status confers therapeutic sensitivity to Cetuximab in combination with Encorafenib, Fluorouracil, and Oxaliplatin 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 mFOLFOX6 for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, it 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.