IMCLONE SYSTEMS FDA approves cancer drug involved in Martha Stewart stock-trading case

The drug has proved effective for tumor reduction in some cases.
WASHINGTON (AP) -- Erbitux, the drug at the center of the stock-trading scandal that brought Martha Stewart to trial, won government approval this week 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.
What it does
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 in combination with a common chemotherapy.
"The fact that it's an effective therapy for tumor reduction is in itself likely to be a benefit to patients," said the FDA's oncology chief, Dr. Patricia Keegan.
Erbitux started making headlines in 2001 as manufacturer ImClone Systems became the darling of the biotechnology circuit, calling the drug a major advance. 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.
Stock plummets
The rejection sent ImClone's stock plummeting. Then came word that the company's founder, Sam Waksal, was tipped to the rejection a day early and dumped his stock. He pleaded guilty to securities fraud and is in prison.
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 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 Sam Waksal's brother, said Thursday.
Last year, ImClone and its marketing partner, Bristol-Myers Squibb Co., again sought FDA approval of the drug and provided with new data.
The companies studied 329 colon cancer patients whose disease failed to respond to a standard chemotherapy, irinotecan. The patients got either Erbitux alone or in combination with irinotecan.
Study details
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.
The effect did not last long; median survival for both groups was nine months or less.
Still, patients with advanced colon cancer that had spread to other parts of the body have few other options, and the FDA said for these people, Erbitux may prove important. Larger studies are under way to see if Erbitux might also extend life.
Doctors also are studying Erbitux, known chemically as cetuximab, to see if it might help other tumors, such as head-and-neck cancer, and enhance the effects of radiation in the same way it does chemotherapy.
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.
Bristol-Myers said it will begin shipping Erbitux in two weeks. The company would not release a price. Doctors and financial analysts have speculated the drug will cost about $30,000 for a year's treatment.