FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600E Mutation

On February 24, the FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test.

For more information, read the FDA announcement and the Pfizer press release.

Posted on 3/4/2026