FDA May Not Require New Clinical Trials for Erbitux™

The experimental drug Erbitux™, viewed by many doctors as a promising treatment for some cases of advanced colorectal cancer, may not need additional clinical trials beyond one already underway in Europe.

The drug's manufacturer, ImClone Systems, announced following a meeting with the U.S. Food and Drug Administration that regulators may be willing to consider approval of Erbitux on the basis of more complete data from a trial already completed in the United States as well as data from a trial being conducted by Merck of Germany.

The FDA two months ago refused to proceed with ImClone's application for Erbitux, citing insufficient information about patients included in the U.S. clinical test of the drug, which had been expected to reach the market later this year.

Erbitux is a monoclonal antibody designed to target and bloxk the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells.

ImClone tested the rug on 120 patients with colorectal cancer who were not responding to irinotecan, an existing drug, and reported tumor shrinkage in 22.5 percent of the patients, who were given both Erbitux and irinotecan.

The European study is a randomized, multi-center clinical trial evaluating the combination of Erbitux and irinotecan and Erbitux alone in patients with irinotecan-refractory colorectal cancer. ImClone will continue discussions regarding the European study with the FDA for their review, comments and approval.

"We view the meeting with the FDA as very productive. The meeting provides us with direction on an approach and a process for resubmitting the Erbitux Biologics License Application, which is expected to include both U.S. and European clinical trial data," said Samuel D. Waksal, PhD, President and CEO of ImClone.

"We assured the FDA that we are committed to working closely with them to resolve issues raised in the Refusal to File letter, and on our approach moving forward," added Waksal.

If the FDA were to accept the new approach, analysts said Erbitux could reach the market from the middle of 2003 to early 2004 -- a year to 18 months later than ImClone's initial expectations, but much earlier than if new trials had been required.

Other Sources: ImClone, NY Times, Washington Post