• uropean approval is based on results from the Phase 3 BREAKWATER trial, which demonstrated that encorafenib in combination with cetuximab and mFOLFOX6 demonstrated a statistically significant improvement in the dual primary endpoints of objective response rate (ORR) and  progression-free survival (PFS), and a significant overall survival (OS) benefit, reducing the risk of death by 51% vs oxaliplatin-based chemotherapy with or without bevacizumab
• This regimen is the first and only combination with a BRAF-targeted therapy approved for the first-line treatment of adult patients with BRAF^V600E-mutant mCRC

Laboratoires Pierre Fabre announced today 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 the results from the Phase 3 BREAKWATER trial, which assessed the efficacy and safety of BRAFTOVI^® in combination with cetuximab and mFOLFOX6 in patients with previously untreated BRAF^V600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.

Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: "We are extremely pleased to be able 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 EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited."

In the Phase 3 BREAKWATER trial, the regimen of BRAFTOVI^® in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with oxaliplatin-based chemotherapy with or without bevacizumab (median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P<0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary 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.