FDA May Widen Approval of Erbitux in Treatment of Colon Cancer

The makers and marketers of Erbitux announced today that their late-stage study of the colon cancer drug was a success, a fact that may lead to broader usage of the medication. ImClone, producer of Erbitux, and Bristol-Myers Squibb, who markets the drug in the U.S., reported that the drug was valuable in slowing the progress of colon cancer in patients who had not received prior treatment.

Currently, the U.S. Food and Drug Administration (FDA) has approved Erbitux only for patients on whom chemotherapy was not successful. The new findings may very well spur the FDA to expand its “label” for the drug. The companies plan to present their research at the American Society of Clinical Oncology’s annual meeting in Chicago this coming June.

“Despite advancements, metastatic disease remains difficult to treat,” said Dr. Eric Rowinsky, Chief Medical Officer and Senior Vice President of ImClone Systems. “This study demonstrates the potential benefit of adding Erbitux to first-line treatment of metastatic colorectal cancer.”

According to the drug makers, their study, known as the CRYSTAL study and conducted by the German-based Merck KGaA, “met the primary endpoint of increasing median duration of progression-free survival,” proving more effective than merely chemotherapy alone. The study included 1,000 patients.

If Erbitux is indeed approved as a first-line treatment of colon cancer, it will be competing with Genentech’s Avastin, which has proved to be rather successful in retarding the disease’s progression and improving life expectancy among patients. Avastin is also significantly cheaper than Erbitux and apparently comes with fewer side effects.

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