The FDA has granted full approval to encorafenib (Braftovi) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy (mFOLFOX6 or FOLFIRI) for adults with metastatic colorectal cancer that carries the BRAF V600E mutation. This decision upgrades an earlier accelerated approval to a standard treatment based on strong survival results.
The approval is based on the phase 3 BREAKWATER trial. In the study, the combination therapy showed better results than standard chemotherapy. The overall response rate was 61% compared with 40% for standard treatment. Median progression-free survival was 12.8 months versus 7.1 months, and median overall survival was 30.3 months compared with 15.1 months, nearly doubling survival time.
The treatment is for patients who have not received prior therapy and have the BRAF V600E mutation. Encorafenib is taken by mouth once daily, along with intravenous cetuximab and chemotherapy every two weeks. Common side effects include fatigue, fever, nausea, diarrhea, rash, and low blood counts. This approval is important because BRAF V600E–mutant colorectal cancer is usually aggressive and difficult to treat, and this new combination sets a new standard for first-line therapy in this group.