cetuximab + encorafenib + folinic acid + fluorouracil + irinotecan

Erbitux + encorafenib + folinic acid + fluorouracil + irinotecan is a combination regimen consisting of two targeted therapies—cetuximab (Erbitux), an anti-EGFR monoclonal antibody, and encorafenib (Braftovi), an oral small-molecule BRAF inhibitor—paired with the FOLFIRI chemotherapy backbone (folinic acid, fluorouracil, and irinotecan). This combination is indicated for the first-line treatment of adult patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. By simultaneously targeting BRAF V600E and EGFR, the regimen overcomes EGFR-mediated feedback reactivation that typically limits the efficacy of BRAF inhibitors alone, while the FOLFIRI backbone provides cytotoxic tumor debulking. In the Phase 3 BREAKWATER trial (NCT04607421), the combination demonstrated statistically significant and clinically meaningful improvements in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to standard-of-care chemotherapy. The FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy (including FOLFIRI or mFOLFOX6) on February 24, 2026.

Other names

Braftovi + cetuximab + FOLFIRIBraftovi + Erbitux + FOLFIRIEC + FOLFIRIEC-FOLFIRIEC-FOLFIRI regimenencorafenib + cetuximab + FOLFIRIencorafenib + Erbitux + FOLFIRIencorafenib, cetuximab, and FOLFIRIencorafenib plus cetuximab plus FOLFIRIErbitux + encorafenib + FOLFIRIErbitux + encorafenib + folinic acid + fluorouracil + irinotecan