Accelerated FDA Approval of Erbitux for Colorectal Cancer Sought

ImClone Systems has reapplied to the U.S. Food and Drug Administration for accelerated approval of the colorectal cancer drug Erbitux.

The company said it would request a priority review for Erbitux, which is used in combination with the chemotherapy drug irinotecan for treatment of advanced colorectal cancer.

Analysts said they anticipate that the FDA will grant the priority review, which means ImClone and its partner, Bristol-Myers Squibb, will find out within six months if they can start marketing the drug in the United States.

ImClone first applied for FDA approval for Erbitux in 2001, but the application was denied. The FDA said trials on the drug had been poorly structured and it could not determine if patients' improvements were a result of Erbitux, the irinotecan or the combination of both.

Earlier this year, the FDA agreed to allow ImClone and Bristol-Myers to use data from a 329-patient European trial conducted by Merck KGaA's l in its new application. The German company has the rights to Erbitux outside North America.

Other sources: ImClone, FDA