Merck's Erbitux European filing still on schedule

Published: 28-Mar-2003

Following an external review of data from its European pivotal clinical trial of Erbitux (cetuximab, C225), Merck KGaA is confident that the drug meets regulatory requirements for application to the European Agency for the Evaluation of Medicinal Products (EMEA).


Following an external review of data from its European pivotal clinical trial of Erbitux (cetuximab, C225), Merck KGaA is confident that the drug meets regulatory requirements for application to the European Agency for the Evaluation of Medicinal Products (EMEA).

The company's plan to file for approval of Erbitux with the EMEA in mid-2003 remains on track, and subject to regulatory approval, the Europe-wide introduction of Erbitux is scheduled to take place in 2004.

The independent radiologic assessment committee has just completed its analysis of the data from the clinical trial involving 330 patients with irinotecan-refractory colorectal cancer. In Europe, there are about 360,000 new cases of colorectal cancer diagnosed each year. Erbitux, an investigational monoclonal antibody, is the most advanced product in Merck KGaA's oncology pipeline. The rights to develop and market Erbitux outside North America have been licensed from ImClone Systems, of New York.

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