US-based Pfizer (NYSE: PFE) has announced receiving an indication extension approval from the US Food and Drug Administration (U.S. FDA) for Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.
Braftovi’s Existing Approval and Pfizer’s Rights
Braftovi, an oral small molecule kinase inhibitor targeting BRAF V600E, is already approved in the US, when combined with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation. Pfizer holds exclusive rights to Braftovi in the U.S., Canada, Latin America, Middle East, and Africa. Concurrently, Ono Pharmaceutical Co., Ltd., Medison, and Pierre Fabre have respective exclusive commercialization rights to the drug in Japan and South Korea, Israel, and all other countries, including Europe and Asia (excluding Japan and South Korea).
Phase III BREAKWATER Study Results and FDA Approval
The FDA’s approval was based on positive results from the Phase III BREAKWATER study, which met one of the dual primary endpoints of confirmed overall response rate (ORR). The study demonstrated a statistically significant improvement over the standard of care: an ORR of 61% for Braftovi in combination with cetuximab and mFOLFOX6 compared with an ORR of 40% for chemotherapy, with or without bevacizumab (p=0.0008). The overall tolerability of the combination was good, with a safety profile consistent with previous findings.-Fineline Info & Tech
