ImClone Systems Incorporated (NASDAQ: IMCL) has just announced that ERBITUX(R) has received marketing authorization in Japan for use in treating patients with advanced or metastatic colorectal cancer (mCRC).
This approval will allow the use of ERBITUX to treat Japanese patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent CRC, and it will allow 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.
Bristol-Myers Squibb (NYSE: BMY) has been Imclone’s commercialization partner. We would also note that Merck KGAA (the German Merck, not U.S.) was also in the pact that was sent in for approval back in 2007.
Jon C. Ogg
July 16, 2008