FDA Asks for More Information on Erbitux, Delaying Planned Introduction

The U.S. Food and Drug Administration has asked for more information on Erbitux, an experimental drug under review for the treatment of colorectal cancer, according to ImClone Systems Inc.

ImClone, which filed for marketing approval of Erbitux on October 31, said it plans to meet with the FDA as soon as possible to discuss what information needs to be provided to regulators. It then will be able to assess how long this will delay its application, the company said.

ImClone had hoped to have the drug on the market in the first half of 2002. Company officials expressed hope that this development would not delay introduction more than three months.

``We will be working closely with the FDA,'' said Samuel D. Waksal, PhD, President and Chief Executive Officer of ImClone Systems Inc. "Our goal is to get Erbitux FDA-approved as soon as possible so that it is accessible to patients suffering from this serious form of cancer.''

Erbitux is an investigational monoclonal antibody designed to target and block the epidermal growth factor receptor (EGFR), which is expressed on the surface of some cancer cells.

In February 2001, The FDA gave ImClone Systems Fast Track designation in February 2001 for Erbitux in the treatment of irinotecan-refractory colorectal cancer.

Other Sources: FDA, ImClone