NICE rejects Erbitux for latest cancer indication

The National Institute for Health and Clinical Excellence (NICE), the UK advisory body responsible for evaluating the effectiveness of drugs and clinical treatments in England and Wales, has issued preliminary guidance rejecting the use of Merck Serono's Erbitux (cetuximab) in combination with radiotherapy for the treatment of locally advanced head and neck cancer.

The German-Swiss drugmaker, which developed the drug together with the USA's ImClone Systems and Bristol-Myers Squibb, noted that the NICE's guidance is contrary to that issued by the Scottish Medicines Consortium, adding that its new recommendation is made under the new Single Technology Appraisal process and does not supersede decisions made by the SMC.

According to Merck Serono, the NICE has based its decision on the fact that a key international clinical trial of Erbitux is not entirely representative of the UK population. However, the NICE's Appraisal Consultation Document points out that the agent does prolong patient survival compared with radiotherapy alone.