Pfizer Inc.'s oral anticancer drug Braftovi gets FDA approval for treating colorectal cancer.

The U.S. Food and Drug Administration (FDA) officially approved the oral anti-cancer drug Braftovi, developed by Pfizer Inc. (PFE.US) in collaboration with Ono Pharmaceutical of Japan, for use in first-line combination therapy for the treatment of colorectal cancer. This decision was based on data from Pfizer Inc.'s Phase 3 BREAKWATER clinical trial. The FDA has allowed this once-daily medication to be used as part of a combination therapy for previously untreated metastatic colorectal cancer patients with the BRAF V600E mutation. Following the achievement of one of the dual primary endpoints related to confirmed overall response rate in the BREAKWATER study, the FDA granted accelerated approval for the same indication for Braftovi in December 2024. Regarding the other dual primary endpoint of progression-free survival, the FDA stated that Braftovi in combination with the anti-cancer drug cetuximab extended the median progression-free survival to 12.8 months in patients with newly diagnosed BRAF V600E-mutant metastatic colorectal cancer. The active ingredient in Braftovi, encorafenib, is an oral small molecule BRAF inhibitor. Data shows that BRAF mutations occur in up to 15% of patients with metastatic colorectal cancer, and these patients have a poor prognosis. The BRAF V600E mutation is the most common BRAF mutation, and patients with this mutation have a mortality rate more than twice that of patients with wild-type BRAF.