Pierre Fabre Laboratories has received a positive opinion from the European Medicines Agency’s CHMP recommending approval of BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX for the first‑line treatment of adults with BRAFV600E‑mutant metastatic colorectal cancer.
The opinion, which now passes to the European Commission for a final decision later this year, is underpinned by results from the phase 3 BREAKWATER trial. The study assessed the combination against oxaliplatin‑based chemotherapy with or without bevacizumab in previously untreated patients.
According to the company, the regimen delivered statistically significant improvements in both dual primary endpoints: objective response rate and progression‑free survival.
Median progression‑free survival reached 12.8 months compared with 7.1 months for chemotherapy with or without bevacizumab, while the objective response rate in the primary analysis set was 60.9 per cent versus 40%. A confirmed objective response was observed in 65.7% of patients compared with 37.4% in the comparator arm.
In an interim analysis, the combination also demonstrated a statistically significant and clinically meaningful overall survival benefit, with median overall survival of 30.3 months versus 15.1 months, reducing the risk of death by 51%.
Eric Ducournau, Chief Executive Officer at 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.”
Safety findings were consistent with known profiles of the individual agents, with the most frequent treatment‑related adverse events including nausea, anaemia, diarrhoea and decreased appetite.
BRAFTOVI in combination with cetuximab already holds EU approval for previously treated BRAFV600E‑mutated metastatic colorectal cancer, granted in 2020.
