Merck Serono, a division of Merck KGaA, announced that marketing authorization has been granted in Japan for the use of Erbitux (cetuximab) in treating patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (CRC). On the basis of the submitted data, the label allows the use of Erbitux plus irinotecan in 2nd and further lines of metastatic colorectal cancer (mCRC).

Erbitux was approved following the submission by Merck Ltd. Japan to the Ministry of Health, Labor and Welfare (MHLW) on January 31, 2007, a company press release said.

"With the increasing incidence of colorectal cancer in the Japanese population, this approval will bring a much needed new treatment option for these cancer patients," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono.

The Japanese submission was mainly based on data from six different studies: two international phase III studies - the NCIC CTG (National Cancer Institute of Canada Clinical Trial Group) CO.17 study and EPIC (European Prospective Investigation of Cancer), two European studies - BOND (Bowel Oncology with Cetuximab Antibody) and MABEL (Monoclonal Antibody Erbitux in a European Pre-License), and two studies conducted in Japanese patients.

"Merck Serono is very pleased to be able to bring this valuable treatment option to patients and physicians in Japan, and to help to improve outcomes for cancer sufferers," said Wayne Paterson, president of Merck Serono Japan.

In Japan, the incidence of CRC has increased markedly during the last 50 years7 with currently around 95,651 cases every year. It has become the most common cancer among women and the second most common among men, after stomach cancer. Colorectal cancer is the third-leading cause of cancer mortality in Japan, accounting for around one in seven cancer deaths8 - a figure which is in part related to the number of people who first present with metastatic CRC (approximately 25% of patients).

Erbitux was first approved for the treatment of mCRC in Switzerland in December 2003. It was approved for use in the United States by the FDA in February 2004, followed by EMEA approval in June 2004. The development of Erbitux in Japan was based on a collaborative effort between Merck KGaA, ImClone Systems Inc., Bristol-Myers Squibb Company, Merck Ltd. Japan and Bristol-Myers K.K.

Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumour cells and the spread of tumours to new sites. It is also believed to inhibit the ability of tumour cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumours, which appears to lead to an overall suppression of tumour growth.

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.