Approval Announcement
NEW YORK—(BUSINESS WIRE) February 24, 2026 — Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. This approval is based on results from the global Phase 3 BREAKWATER trial (NCT04607421).
Key Features of the Approved Regimen
The Braftovi combination regimen is the only approved targeted regimen for first-line BRAF-V600E mutant metastatic colorectal cancer.
Pivotal Trial Results
Pivotal results from the Phase 3 portion with mFOLFOX6 demonstrated a 51% risk reduction in death and a 47% risk reduction in disease progression or death compared to standard chemotherapy.
Indication Flexibility
The expanded indication enables flexibility to use Braftovi with different fluorouracil-based chemotherapy regimens (mFOLFOX6 or FOLFIRI).
Basis for Full Approval Conversion
The conversion from the December 2024 accelerated approval to full approval is based on significant benefits in progression-free survival (PFS) and overall survival (OS) from the Phase 3 portion of the study, as well as objective response rate (ORR) results from the FOLFIRI combination cohort.
Expert and Executive Comments
“This landmark approval... validates that this targeted therapy can impact outcomes for people living with an aggressive, hard-to-treat cancer,” said Aamir Malik, Executive Vice President and Chief U.S. Commercial Officer at Pfizer. “Braftovi is uniquely positioned to redefine first-line treatment and establish a new standard of care.”
Dr. Scott Kopetz of The University of Texas MD Anderson Cancer Center noted, “This approval gives oncologists confidence to use encorafenib plus cetuximab... as a first-line standard of care... providing the robust evidence we need to make treatment decisions that can meaningfully impact patient outcomes.”
Safety Profile
The safety profile remained consistent with known data for each agent. Common side effects (≥25%) for the mFOLFOX6 regimen included peripheral neuropathy, nausea, and fatigue. For the FOLFIRI regimen, common side effects included nausea, diarrhea, and alopecia.
