The Associated Press
WASHINGTON - Erbitux, the drug at the center of the Martha Stewart stock scandal, won government approval Thursday as a treatment for colorectal cancer patients who have run out of other options.
The Food and Drug Administration cautioned that Erbitux has not been shown to extend patients' lives. But in studies, it did shrink some patients' tumors and delay tumor growth, especially when used together with another common cancer drug.
Erbitux is one of a new class of cancer medicines designed to specifically target and disrupt certain molecules that spur tumor growth.
But it has gotten more attention on Wall Street than in hospitals because of the Stewart case.
Manufacturer ImClone Systems initially sought FDA approval in 2001. But the agency said the company's studies were so poorly done that scientists couldn't even evaluate whether Erbitux actually helped patients.
That rejection sent ImClone's stock plummeting. Chief executive Sam Waksal is in prison after pleading guilty to securities fraud for dumping his stock just before the news became public. Now his friend, Stewart, is on trial, accused of lying and securities fraud.
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