The European Medicines Agency has been formally notified by Merck KGaA of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Erbitux (cetuximab), 5 mg/mL solution for infusion.

 

On 18 March 2011, Merck KGaA submitted an application to extend the marketing authorisation for Erbitux to the treatment of non-small-cell lung cancer (NSCLC). At the time of the withdrawal, the application was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

 

Erbitux was first authorised in the European Union on 29 June 2004 and it is currently indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer It is also indicated for the treatment of patients with squamous cell cancer of the head and neck.

 

In its official letter, the company stated that it decided to withdraw the application because the data currently available suggest that further data will be required to overcome the uncertainties raised by the CHMP.

 

Erbitux continues to be authorised in the currently approved indications.

 

More information about Erbitux and the state of the scientific assessment at the time of the withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency’s website after the 17-20 September 2012 CHMP meeting.

 

Posted on the EMA website on 19 Sep 2012