FDA approves combination regimen for metastatic colorectal cancer (Healio)

The FDA has granted accelerated approval to a combination therapy led by encorafenib (Braftovi) for patients with BRAF V600E-mutant metastatic colorectal cancer, based on findings from the BREAKWATER trial. Patients treated with encorafenib, cetuximab, and chemotherapy (mFOLFOX6) demonstrated a higher response rate (61% vs. 40%) and longer median response duration (13.9 vs. 11.1 months) compared to the control group. Common side effects included neuropathy, nausea, and fatigue, with grade 3/4 lab abnormalities like elevated lipase and low neutrophils. Ongoing studies will further evaluate progression-free and overall survival.