Scott Kopetz, MD, PhD, explains how the BREAKWATER trial aligns with the FDA’s Project FrontRunner initiative by using early response rate data to support accelerated approval in BRAF V600E-mutated metastatic colorectal cancer.

He details newly reported findings showing that adding encorafenib and cetuximab to FOLFOX nearly doubled PFS and OS compared to standard chemotherapy. He also discusses the potential of a chemotherapy-free regimen, subgroup trends, and upcoming data from a FOLFIRI-based cohort.