Posted by Michael Wonder on 24 Feb 2026
FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
24 February 2026 - Today, the FDA granted traditional approval to encorafenib (Braftovi, Array BioPharma, a subsidiary of Pfizer) 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 authorised test.
Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024.
