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The single agent gamble

After the Fall

The single agent gamble

ImClone Systems Inc.'s high-risk regulatory strategy involved attempting to gain accelerated approval based on data from an open-label Phase II trial in colorectal cancer that was not designed to support registration. The approach forced the company into arguing the counter-intuitive notion that Erbitux has no efficacy as a stand-alone treatment - an argument that the FDA didn't buy.

IMCL (New York, N.Y.) apparently was forced to take this position because the only regimen tested in the Phase II trial was Erbitux (C225) combined with irinotecan, which causes serious toxicities. But if Erbitux had anti-tumor activity as a single agent, FDA would logically require a trial to determine if it could be used as a monotherapy, thereby sparing patients the risks associated with irinotecan. Thus, the success of IMCL's bid to gain accelerated approval based on the Phase II trial hinged on its ability

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