European Approval of Erbitux to Be Sought in Early 2003

German pharmaceutical company Merck said that based on an early internal analysis of a clinical trial, it expects to apply in the first half of 2003 for European approval of the cancer drug Erbitux.

An application for U.S. approval of the drug, which is being co-developed by the biotech firm ImClone Systems Inc, was turned back a year ago by the Food and Drug Administration, which cited insufficient information about patients included in the U.S. clinical test of the drug (see earlier Colorectal Cancer Week story).

ImClone and its U.S. partner, Bristol-Myers Squibb, subsequently initiated new clinical trials and also said they would use data from the clinical trial conducted by Merck as part of their efforts to obtain approval in the United States.

Merck said it is currently evaluating a trial of 330 patients with advanced colorectal cancer who did not respond to a standard therapy.

"Results of an external analysis of the trial data by an independent
radiologic assessment committee (IRAC) are expected to be completed in March 2003," a Merck spokesperson said..

"Subject to regulatory approval, the Europe-wide introduction of (the drug) is scheduled to take place in 2004," Merck said in a statement.

Other Sources: Merck