FDA gives nod to ImClone drug

WASHINGTON -- Erbitux, the drug at the center of the stock trading scandal that brought Martha Stewart to trial, won government approval yesterday as a last-ditch treatment for advanced colorectal cancer.

Doctors believe roughly 20,000 patients a year might benefit from Erbitux, one in a new type of cancer medicines that jam chemical signals that spur tumor growth.

But they caution that Erbitux is not a miracle drug. Patients have clamored for the drug since its roller-coaster attempts at Food and Drug Administration approval began in 2001.

"We hope for miracle drugs but the reality is the way we make improvements in cancer is incremental," said Dr. Ronald Blum, director of the cancer center at New York's Beth-Israel Medical Center.

Erbitux's incremental advance is important, he said. It blocks a growth factor on colorectal tumor cells and enhances the punch of standard chemotherapy.

The FDA cautioned that studies have not shown whether Erbitux can help patients live longer. But it can shrink some tumors and delay their growth, especially when Erbitux is used with a common chemotherapy.

Erbitux started making headlines in 2001 as manufacturer ImClone Systems became the darling of the biotechnology circuit. But in December of that year, the FDA rejected ImClone's original application, saying the company's studies were so poorly done that there was no way to tell whether Erbitux actually helped patients. The rejection sent ImClone's stock plummeting. Then came word that the company's founder, Samuel Waksal, was tipped to the rejection a day early and dumped his stock. He pleaded guilty to securities fraud and is serving a prison sentence.

Stewart, his friend, is now on trial, accused of lying to investigators about why she sold her nearly 4,000 shares of ImClone around the same time as Waksal. She has denied any wrongdoing.

"This approval is a vindication for those who always believed in the promise and prospects for Erbitux," Dr. Harlan Waksal, ImClone's former chief executive and Waksal's brother, said yesterday.

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

ImClone shares were halted at $34 on Nasdaq just before the FDA approved Erbitux. They resumed trading in after-hours, rising $10.44 to $43.80. Bristol-Myers fell 14 cents to $29.89 on the New York Stock Exchange.