Merck KGaA has submitted an application to the European Medicines Agency (EMEA) and Swissmedic to extend the use of the targeted cancer therapy, Erbitux (cetuximab), for the treatment of squamous cell carcinoma of the head and neck (SCCHN).
The proposed new indication is for the use of Erbitux in combination with radiation for locally advanced SCCHN and also as monotherapy in patients with recurrent and/or metastatic disease where prior chemotherapy has failed. Erbitux gained its first approval for metastatic colorectal cancer in Switzerland in December 2003.
Erbitux is a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR) responsible for tumour growth and spread in a number of different cancer types. Its benefits in various EGFR-expressing cancer settings continue to be studied. These cancer types include first and second line colorectal cancer, metastatic SCCHN, pancreatic, and non-small cell lung cancer.
Dr. Bernhard Ehmer, Head of Merck KGaA Oncology said, “Only about 33 per cent of patients are still alive five years after diagnosis and, unfortunately, there are still too few treatment options. Erbitux has shown significant benefits for patients with this disease, and we hope to see it become a new important treatment option in the near future.”
Results from an international, Phase III study of 424 patients, showed that combining Erbitux with radiation significantly prolonged median survival and reduced the risk of locoregional failure compared with radiation alone.
In addition, ImClone Systems Incorporated and Bristol-Myers Squibb Company, the development and marketing partners for Erbitux in North America, have filed a supplemental Biologics License Application (sBLA) to the US FDA for approval of Erbitux as a single agent and in combination with radiation for the treatment of SCCHN using a filing package similar to Merck’s.