Pierre Fabre Laboratories receives CHMP positive opinion for 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)

This positive CHMP opinion is based on results from the Phase 3 BREAKWATER trial, which showed that encorafenib in combination with cetuximab and mFOLFOX6 demonstrated a statistically significant improvement in the dual primary endpoints of objective response rate (ORR) and...