Switzerland first to approve Erbitux
The Swiss Agency for Therapeutic Products (Swissmedic) has approved the use of Merck Erbitux (cetuximab) for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan.
The Swiss Agency for Therapeutic Products (Swissmedic) has approved the use of Merck Erbitux (cetuximab) for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan.
The Swiss authorisation allows doctors to administer Erbitux in combination with irinotecan.
This is the first approval of Erbitux anywhere in the world and went through under an accelerated registration procedure. Merck submitted applications at the end of June 2003 for approval of Erbitux to both Swissmedic and the European Agency for the Evaluation of Medicinal Products (EMEA). EU marketing authorisation is expected in mid-2004. Upon receiving the Swiss notification, Merck immediately began shipment of the cancer medicine to Switzerland.
The Swiss approval was based on a large multi-centre clinical trial conducted in 11 European countries in 57 hospitals with more than 300 patients diagnosed with advanced metastatic colorectal cancer. In the so-called BOND study, Erbitux, when used in combination with irinotecan chemotherapy, benefited more than half of patients. It shrank tumours in 23% and stopped tumour growth in an additional 33% of patients.
Merck KGaA licensed the right to market Erbitux outside the US and Canada from ImClone Systems in 1998. In Japan, Merck KgaA has co-exclusive marketing rights with ImClone Systems.