FDA grants full approval to Pfizer’s BRAFTOVI (encorafenib) + cetuximab for first-line BRAF V600E-mutant metastatic colorectal cancer, converting accelerated approval from BREAKWATER trial data. Quick update on this pivotal oncology advance.
Written By: Pharmacally Medical News Desk
Pfizer announced on February 24, 2026, that the U.S. FDA has granted full approval to BRAFTOVI (encorafenib) combined with cetuximab and fluorouracil-based chemotherapy for first-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC). This converts the December 2024 accelerated approval, based on Phase 3 BREAKWATER trial results showing 51% reduced risk of death (HR 0.49) and 47% reduced risk of progression or death (HR 0.53) versus standard chemotherapy with or without bevacizumab.
Key Approval Details
The regimen now supports flexibility with regimens like mFOLFOX6 or FOLFIRI alongside cetuximab, making it the only targeted first-line option for this mutation affecting 8-12% of mCRC patients. Safety aligns with known profiles, with common adverse reactions including peripheral neuropathy (64%), nausea (54%), and fatigue (53%) in the mFOLFOX6 arm; 14% discontinued BRAFTOVI due to adverse events.
This development follows our prior coverage of BREAKWATER results published on 19 February 2026: Pfizer Advances BRAFTOVI in Colorectal Cancer with New BREAKWATER Results.
Reference
U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer, 24 February 2026, U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer | Pfizer
Pfizer Advances BRAFTOVI in Colorectal Cancer with New BREAKWATER Results, 19 February 2026, https://pharmacally.com/pfizer-advances-braftovi-in-colorectal-cancer-with-new-breakwater-results/