NICE expands positive recommendation for Erbitux as first-line treatment for RAS wild-type mCRC

Merck, a leading science and technology company, announced  that the UK National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux (cetuximab) in combination with either FOLFIRI or FOLFOX as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC). Erbitux has long been established and reimbursed as a first-line standard-of-care treatment option in most European countries and many other countries worldwide.

"The NICE decision is great news for patients and their families in England, as it now means they will have access to this effective first-line treatment," said Maya Martinez-Davis, global head of Oncology Franchise for Merck’s biopharma business. "Our efforts in working with NICE to reach this important milestone are part of our relentless commitment to bringing tailored, effective therapies to patients worldwide."

This decision expands the previous NICE recommendation, which endorsed the use of Erbitux in combination with either FOLFOX or FOLFIRI solely for patients whose cancer had spread only to the liver (liver-limited disease). It is based on robust data from Phase III clinical studies having demonstrated that Erbitux in combination with either FOLFIRI or FOLFOX as a first-line treatment for patients with RAS wild-type mCRC, confers significant benefit in patient outcomes.

"Patients with metastatic colorectal cancer in the UK have very limited access to effective first-line treatments," said Jola Gore-Booth, founder/CEO of the colorectal cancer patient advocacy group, EuropaColon. "We are therefore delighted with NICE’s decision, as it means there is now more choice for patients in England regarding treatment options that they can benefit from."

Both the European Society for Medical Oncology and the US National Comprehensive Cancer Network clinical guidelines also recommend first-line treatment with Erbitux, in combination with either FOLFOX or FOLFIRI, for patients with RAS wild-type mCRC.

Erbitux has obtained marketing authorization in over 90 countries worldwide. To date, more than 480,000 patients with mCRC have been treated with Erbitux.