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- European approval is based on results from the Phase 3 BREAKWATER trial, which demonstrated that encorafenib in combination with cetuximab andmFOLFOX6 showed statistically significant improvements in the dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS) compared to oxaliplatin-based chemotherapy with or without bevacizumab, with a significant overall survival (OS) benefit and a 51% reduction in the risk of death.
- This regimen is the first and only regimen combining aBRAF-targeted therapy approved for the first-line treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC).
CASTRES, FranceJune 23, 2026 /PRNewswire/ — Laboratoires Pierre Fabre today announced that the European Commission (EC) has approved BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The approval is based on results from the Phase 3 BREAKWATER trial, which evaluated the efficacy and safety of BRAFTOVI® in combination with cetuximab and mFOLFOX6 compared to oxaliplatin-based chemotherapy with or without bevacizumab in treatment-naïve patients with BRAF V600E-mutant mCRC.
Eric Ducournau, Chief Executive Officer of Laboratoires Pierre Fabre, stated: “We are very pleased to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAF V600E-mutant mCRC. Today’s European Commission decision marks an important milestone as it approves the only targeted therapy for the first-line treatment of this patient population in the EU, helping to address a significant unmet need for patients and clinicians, who have had limited treatment options.”
In the Phase 3 BREAKWATER trial, BRAFTOVI® in combination with cetuximab and mFOLFOX6 demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to oxaliplatin-based chemotherapy with or without bevacizumab (median PFS of 12.8 months vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P<0.001), and a statistically significant improvement in the dual primary endpoint of ORR in the primary efficacy analysis set (60.9% vs. 40.0%; odds ratio 2.44; 95% CI: 1.40-4.25; P<0.001). A confirmed ORR was observed in 65.7% of patients (95% CI, 59.4 to 71.4), compared to 37.4% (95% CI, 31.6 to 43.7) in the oxaliplatin-based chemotherapy with or without bevacizumab group in the overall population.