Pierre Fabre Laboratories receives CHMP positive opinion 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)
- This positive CHMP opinion is based on results from the Phase 3 BREAKWATER trial, which showed 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 chemotherapy with or without bevacizumab
- The European Commission decision is expected later this year. If approved, the regimen will be the first and only combination with BRAF-targeted therapy approved for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer
CASTRES, France, May 25, 2026 /PRNewswire/ -- Pierre Fabre Laboratories announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The positive opinion will be submitted to the European Commission (EC) with a decision on EU marketing authorisation expected later this year.
Eric Ducournau, Chief Executive Officer, Pierre Fabre Laboratories, said: "Today's positive CHMP opinion marks an important step towards a targeted approach for patients with BRAFV600E-mutant metastatic colorectal cancer. If approved, it would be the only approved targeted therapy in the EU for this patient population in the first-line setting. This milestone reflects Pierre Fabre Laboratories' commitment to advancing meaningful innovation in oncology and to working in close partnership with the scientific and medical community to address areas of high unmet need."
The CHMP positive opinion is based on 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.
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 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.
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