Laboratoires Pierre Fabre has announced 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.
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.”
“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,” said Nùria Perez-Cullel, head of medical, patient, and consumer affairs, Laboratoires Pierre Fabre. “We are committed to bringing this treatment combination to patients with BRAFV600E- mutant mCRC, where limited treatment options, specifically for these patients, exist. We continue to advance our clinical development efforts to help bring new targeted cancer therapies to patients who need them the most.”
Braftovi in combination with cetuximab was approved by the EC in 2020 for the treatment of adults with BRAFV600E-mutated mCRC who had received prior systemic therapy, supported by results from the randomised, controlled, open-label, multi-centre Phase 3 BEACON CRC trial.
