Is Another Setback in Store for ImClone?

If ImClone and Bristol-Myers try to get Erbitux approved as a stand-alone cancer drug, it will be following in the regulatory footsteps blazed by AstraZeneca(AZN Quote) and its similar, targeted cancer drug, Iressa. On Sept. 24, an FDA advisory panel recommended Iressa's approval as a stand-alone treatment for advanced lung cancer, based on data showing the drug shrank tumors in 11% of patients. The positive nod was granted despite other studies in which Iressa failed to show any efficacy when used in combination with existing chemotherapy drugs. The FDA has yet to make a final decision on Iressa's approval.

ImClone long maintained that Erbitux worked only in combination with other chemotherapy drugs. In fact, the company chose to ignore FDA advice to pursue approval as a single-agent treatment, usually a less-risky regulatory approach.

ImClone has confirmed the start of the 250-patient monotherapy trial to bolster the findings presented at ASCO, for Erbitux, but has not offered any details. According to a study protocol found on the National Institute of Health's Web site, the new study is being conducted at four hospitals in Florida, Georgia, New York and Texas.

Colon cancer patients eligible for the trial will be given Erbitux only after failing at least two prior rounds of chemotherapy treatment, including the use of oxaliplatin, which was only approved for use in the U.S. in September. This could slow the study's enrollment because finding patients quickly who don't respond to oxaliplatin could be difficult, given that the drug is just making its way into the colon cancer-treatment repertoire.

ImClone and Bristol-Myers also could decide to ditch Erbitux as a colon cancer treatment, and concentrate instead on getting the drug approved for patients with head and neck cancer. Although earlier studies in head and neck cancer have proven disappointing, the company is conducting another, larger study testing the drug in combination with radiation. Results are expected next year.