French pharmaceutical company Pierre Fabre Laboratories announced on Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of 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).

A decision by the European Commission on EU marketing authorisation is expected later this year.

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.

According to the company, the regimen of encorafenib in combination with cetuximab and mFOLFOX6 demonstrated a statistically significant improvement in the dual primary endpoints of objective response rate and progression-free survival, and a significant overall survival benefit, reducing the risk of death by 51% vs chemotherapy with or without bevacizumab.