Here is the English translation of the Chinese title: **Pierre Fabre Laboratories Receives Positive CHMP Opinion for BRAFTOVI® (Encorafenib) in Combination with Cetuximab and FOLFOX (Fluorouracil, Folinic Acid, and Oxaliplatin) for the First-Line Treatment of Adult Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer (mCRC)**

• This positive CHMP opinion is based on results from the Phase 3 BREAKWATER trial, which demonstrated that encorafenib in combination with cetuximab and mFOLFOX6 achieved statistically significant improvements in the dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS), along with a significant overall survival (OS) benefit and a 51% reduction in the risk of death, compared to bevacizumab with or without chemotherapy.
• A decision from the European Commission is expected later this year. If approved, this regimen would be the first and only BRAF-targeted therapy combination approved for the first-line treatment of adult patients with BRAF ^V600E-mutant metastatic colorectal cancer.

CASTRES, FranceMay 25, 2026 /PRNewswire/ — Pierre Fabre Laboratories today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending approval of 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 positive opinion will be submitted to the European Commission (EC), with a decision on EU marketing authorization expected later this year.

Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories, said: “Today’s positive CHMP opinion marks a significant step forward toward a targeted approach for patients with BRAF ^V600E-mutant metastatic colorectal cancer. If approved, this would be the only targeted therapy approved 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 working closely with the scientific and medical community to address areas of high unmet need.”

The CHMP’s positive opinion is based on results from the Phase 3 BREAKWATER trial, which evaluated the efficacy and safety of BRAFTOVI ^® in combination with cetuximab and mFOLFOX6 in previously untreated patients with BRAF ^V600E-mutant mCRC, compared to oxaliplatin-based chemotherapy with or without bevacizumab.

The BRAFTOVI ^® in combination with cetuximab and mFOLFOX6 regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy with or without bevacizumab (median PFS 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.