ImClone Systems, Inc.’s advanced colorectal cancer drug has now received regulatory approval in Japan.
ERBITUX(R) (cetuximab) has received marketing authorization in Japan for use in treating patients with advanced or metastatic colorectal cancer (mCRC).
Specifically, this approval allows for the use of ERBITUX to treat patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent CRC, and allows the use of ERBITUX plus irinotecan in second and further lines of mCRC.
With this approval, ERBITUX is the first ever EGFR-targeted monoclonal antibody to be submitted for and receive marketing authorization in Japan.
ERBITUX (cetuximab) is a monoclonal antibody (IgG1 Mab) designed …read more

ERBITUX® (Cetuximab) – product of Merck KGaA and ImClone Systems Inc. – has received EU backing as first-line treatment for colon cancer.
According to the European Medicines Agency:
Erbitux can be given as the first drug in colon-cancer treatment in patients who carry an unmutated kras gene, restricting its use to about 65 percent of patients.
Erbitux is the first monoclonal antibody approved by the US FDA for the treatment of advanced colon cancer that has spread to the other parts of the body — either alone or in combination with other treatments.
Read more about the EU backing on Erbitux from Bloomberg.