Erbitux submitted for advanced CRC in Japan

German-Swiss drugmaker Merck Serono and USA-based ImClone Systems have filed an application to the Japanese Pharmaceuticals and Medical Devices Agency for the use of their co-developed drug Erbitux (cetuximab) in patients with advanced colorectal cancer. According to the firms, Erbitux is the first IgG1 monoclonal antibody targeting the epidermal growth factor receptor for which marketing authorization in Japan has been filed.

The Japanese submission was based on data from two European studies, BOND and MABEL, as well as two trials in Japanese patients. The BOND study demonstrated that Erbitux, when used in combination with irinotecan-based chemotherapy in the treatment of patients with metastatic colorectal cancer whose cancer had progressed on irinotecan-based chemotherapy, slowed progression of the disease by more than four months and shrank tumors 50% or more in 22.9% of the 218 patients involved in the combination arm of the trial. In the 1,147-patient MABEL study in mCRC, Erbitux yielded a median survival of 9.2 months in combination with irinotecan finding consistent with that of the BOND trial.