The U.S. FDA on Tuesday granted traditional approval for a first-line combination regimen involving Braftovi, an oral cancer drug developed by Pfizer (PFE) in partnership with companies such as Japan’s Ono Pharmaceutical (OPHLF) (OPHLY) for colorectal cancer.
The decision, based on data from the company’s Phase 3 BREAKWATER trial, permits the marketing of the once-daily drug as part of a combination therapy for previously untreated mCRC patients with a BRAF V600E mutation in their cancers.
In December 2024, the FDA greenlighted Braftovi under its accelerated approval pathway for the same indication after BREAKWATER met one of its dual primary endpoints related to confirmed overall response rate.
Regarding its other dual primary endpoint of progression-free survival, the FDA said that Braftovi, with cancer therapy cetuximab, led to a median PFS of 12.8 months in the study for newly diagnosed BRAF V600E-mutant mCRC patients.