Erbitux approval covers first-line BRAF-mutant cases

An Erbitux approval in Europe has added a first-line targeted treatment option for adults with metastatic colorectal cancer carrying the BRAF V600E mutation.

The European Commission approved an update to the Erbitux (cetuximab) EU label on 26th June 2026. It now covers use with encorafenib and FOLFOX in first-line treatment, and with encorafenib for patients who have received prior systemic therapy.

Merck said the first-line decision was based on the Phase 3 BREAKWATER trial in previously untreated BRAF V600E-mutant metastatic colorectal cancer.

BREAKWATER trial results

In that trial, median progression-free survival was 12.8 months for the cetuximab, encorafenib and FOLFOX combination, compared with 7.1 months for standard-care chemotherapy with or without bevacizumab. Median overall survival was 30.3 months versus 15.1 months.

The study reported a 47% reduction in the risk of progression or death and a 51% reduction in the risk of death. Confirmed objective response rate was 65.7% in the BREAKWATER arm and 37.4% in the control arm.

Serious adverse events occurred in 46.1% of patients in the BREAKWATER arm, compared with 38.9% in the standard-care arm. Safety profiles were consistent with those previously established for each individual agent.

Matthias Wernicke, Head of Global Therapeutic Area Specialty Care in the healthcare business sector of Merck, said: “The approval of Erbitux in combination with encorafenib and FOLFOX marks an important milestone for patients with BRAF V600E-mutant mCRC who can now benefit from a first targeted treatment option in the first-line setting.”

The cetuximab, encorafenib and FOLFOX regimen was endorsed as first-line standard of care by the April 2026 ESMO Clinical Practice Guidelines for patients with metastatic colorectal cancer harbouring the BRAF V600E mutation.

For patients who have already received prior systemic therapy, the European Commission also approved Erbitux with encorafenib on 26th June 2026. In the Phase 3 BEACON CRC trial, that regimen improved median overall survival to 9.3 months from 5.9 months versus the irinotecan-based control, reducing the risk of death by 39%.

Colorectal cancer was the third most commonly diagnosed cancer worldwide in 2022 and the second leading cause of cancer-related deaths, with 1.92 million new cases and about 900,000 deaths, according to the World Health Organisation.