Merck applies to extend use of Erbitux

Published: 20-Jun-2008
Regulatory

Merck KGaA has submitted an application to the European Medicines Agency (EMEA) to broaden the use of the targeted therapy Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).


Merck KGaA has submitted an application to the European Medicines Agency (EMEA) to broaden the use of the targeted therapy Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). The submitted label would extend the use of Erbitux for treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck in combination with platinum-based chemotherapy.

The submission is supported by data from a study investigating the efficacy of Erbitux in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN. The study showed that when added to current standard platinum-based chemotherapy, Erbitux significantly increased the overall survival time for patients.

Erbitux has been licensed in the EU for use in combination with radiotherapy for locally advanced SCCHN since April 3, 2006. In addition, Erbitux was first approved for the treatment of metastatic colorectal cancer (mCRC) after irinotecan

failure in Switzerland in December 2003 and in the EU in June 2004.

Head and neck cancer is the sixth most frequently occurring cancer worldwide.

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