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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.