FDA Approves ImClone Cancer Drug

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 in December of that year 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, domestic diva Stewart, is on trial, accused of lying and securities fraud in dumping her own holdings. She denies wrongdoing.

Last year, ImClone and its marketing partner, Bristol-Myers Squibb Co., again sought FDA approval of the drug, armed with new data.

They studied 329 colon cancer patients whose disease failed to respond to a standard therapy, irinotecan. They were given either Erbitux alone or in combination with irinotecan.

Some 23 percent of patients given the drug combination and 11 percent who got Erbitux alone responded to treatment, meaning their tumors shrank by at least half.

Why did the combination work better? The theory is that Erbitux might restore some of irinotecan's punch.

The effect didn't last long - median survival for both groups was nine months or less.

The FDA approved Erbitux only for advanced colorectal cancer that has spread to other parts of the body, but said for those patients it may provide an important option. Additional studies are under way to see if Erbitux might slow progression of the cancer and extend life.

Erbitux can cause serious side effects including difficulty breathing and low blood pressure, the FDA warned. Administration of the first dose is a particularly risky time.

Occasionally, interstitial lung disease - a scarring of the lungs - has been reported among Erbitux users, but FDA couldn't determine if the drug was the cause. Other side effects include acne-like rash, dry skin, fatigue, weakness, constipation and abdominal pain.

Colorectal cancer is the nation's third most common cancer and the second-leading cancer killer. About 147,500 new cases were diagnosed last year, and it claimed 57,000 lives.

By Lauran Neergaard