BRAFTOVI® (Encorafenib) with Cetuximab and Fluorouracil-based Chemotherapy

The FDA on February 24, 2026, granted traditional approval to BRAFTOVI® in combination with Cetuximab and Fluorouracil-based chemotherapy for the treatment of adult patients with metastatic Colorectal Cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. BRAFTOVI® received accelerated approval in combination with Cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024. BRAFTOVI®  is a product of Array BioPharma Inc., a subsidiary of Pfizer Inc.