US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Tuesday that the European Commission has approved an updated label for Erbitux (cetuximab), allowing its use in combination with encorafenib for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) -- both in first-line treatment in combination with FOLFOX (BREAKWATER regimen) and for patients who have received prior systemic therapy (BEACON regimen).

This decision was based on the Phase 3 BREAKWATER trial, which showed statistically significant improvements in progression-free survival, overall survival and objective response rate versus standard chemotherapy with or without bevacizumab. The regimen reduced the risk of disease progression or death by 47% and the risk of death by 51%, with median overall survival improving to 30.3 months from 15.1 months.

The BREAKWATER trial was conducted by Pfizer in collaboration with Merck and Ono Pharmaceutical.

Merck said the combination with FOLFOX is the first and only approved targeted first-line regimen for adults with BRAF V600E-mutant mCRC. Erbitux is now approved across multiple patient populations and lines of therapy.