Pierre Fabre Laboratories secures CHMP backing for first‑line BRAFTOVI regimen

Data shows survival benefit in BRAFV600E‑mutant metastatic colorectal cancer

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…