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.