Laboratoires Pierre Fabre has secured European Commission approval for Braftovi (encorafenib) in combination with cetuximab and FOLFOX for the first‑line treatment of adults with BRAFV600E‑mutant metastatic colorectal cancer (mCRC).
The decision is based on results from the phase 3 Breakwater trial, which compared the regimen with oxaliplatin‑based chemotherapy with or without bevacizumab in previously untreated patients.
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.”
Breakwater showed that the combination delivered a statistically significant and clinically meaningful improvement in progression‑free survival, with median PFS of 12.8 months versus 7.1 months for chemotherapy.
The regimen also met the dual primary endpoint of objective response rate, achieving 60.9% in the primary analysis set compared with 40%. A confirmed objective response was observed in 65.7% of patients versus 37.4% in the comparator arm.
An interim analysis demonstrated a statistically significant overall survival benefit, with median OS of 30.3 months versus 15.1 months, reducing the risk of death by 51%.
Nùria Perez‑Cullel, Head of Medical, Patient, and Consumer Affairs, Laboratoires Pierre Fabre said: “This EC approval underscores our commitment to improving care for cancer patients, in this case in colorectal cancer, a disease where the incidence continues to rise globally. We are committed to bringing this treatment combination to patients with BRAFV600E- mutant mCRC, where limited treatment options, specifically for these patients, exist.”
Safety findings were consistent with known profiles of the individual agents, with nausea, anaemia and diarrhoea among the most common adverse events.
