June 20, 2008
Merck Files for Label Extension of Cancer Drug
Merck KGaA has submitted an application to the European Medicines Agency to broaden the use of the targeted therapy Erbitux to include first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
The submitted label would extend the use of Erbitux for treatment of patients with recurrent or metastatic squamous cell cancer of the head and neck in combination with platinum-based chemotherapy.
The submission is supported by data from the Extreme study, which showed that when added to current standard platinum-based chemotherapy, Erbitux significantly increased the overall survival time for patients.
The application for the first-line indication will be reviewed by the Committee for Medicinal Products for Human Use. If approved by the European Commission, patients within Europe may then start benefiting from Erbitux as a first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck.