Pfizer Inc. has announced promising results from the Phase 3 BREAKWATER trial involving its BRAFTOVI® combination regimen for patients with BRAF V600E-mutant metastatic colorectal cancer. The study demonstrated a significant 51% reduction in the risk of death and a 47% reduction in disease progression or death compared to standard-of-care treatments. These findings meet the trial's dual primary endpoint of progression-free survival. The BRAFTOVI combination is the first and only regimen with targeted therapy to improve survival outcomes for treatment-naïve patients with this specific mutation. Following accelerated approval by the U.S. FDA in December 2024, these results further establish the regimen's potential to become a new standard of care in precision medicine. Discussions are ongoing with the FDA to potentially convert the accelerated approval to full approval by 2025.