Laboratoires Pierre Fabre receives European Commission Approval for BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)

On June 22, 2026 Laboratoires Pierre Fabre reported that the European Commission (EC) has approved BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-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 BRAFV600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.

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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 BRAFV600E-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.

(Press release, Pierre Fabre, JUN 22, 2026, View Source [SID1234668871])