Word: erbitux
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Dates: during 2002-2002
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...charges against Waksal stem from his attempt to sell $4.9 million of ImClone stock on Dec. 27. He learned on Dec. 26 that the company's application for the cancer drug Erbitux was going to be denied review by the U.S. Food and Drug Administration--news that the company made public after the markets closed on Dec. 28. He is also accused of tipping off his daughter Aliza, who sold $2.5 million of ImClone, and his father Jack, who sold $6.7 million of the stock ahead of the FDA news. Only Waksal has been charged; he denies wrongdoing...
...Erbitux controversy raised questions at last week's congressional hearings on ImClone as to whether FDA protocol encourages insider trading. But agency officials contend that frequent communication with applicants is essential. "If a sponsor chooses to act on that information and insider trade, that's his responsibility," says Robert Temple, director of the FDA's oncology-drug evaluation group. And last week, without naming names, Treasury Secretary Paul O'Neill suggested a solution to the escalating crisis of executives abusing trust. "We ought to hang them from the very highest branches." --With reporting by Andrew Goldstein/Washington and Unmesh Kher...
Twenty years later, Mendelsohn is president of MD Anderson Cancer Center in Houston, and his cancer-fighting approach remains controversial. When his backers at ImClone sought FDA approval for Mendelsohn's Erbitux cancer drug, the agency declined to consider it. By giving cancer patients Erbitux and chemotherapy together in clinical trials, the FDA said, ImClone made it difficult to determine how much impact Erbitux...
Most cancer specialists, though, believe that while Erbitux and the science behind its development are radical, both are solid. Erbitux can home in on a protein beacon found on 80% of tumors, making it a promising candidate for treating a range of cancers, from breast to lung to colon. "Nobody has ever questioned the value or the trustworthiness of the science," says Dr. Larry Norton, head of solid tumor oncology at Memorial Sloan-Kettering Cancer Center in New York City...
Ongoing studies described at a recent cancer conference indicate that Erbitux makes chemotherapy more effective. Patients who had not previously responded to chemotherapy benefited when the same chemotherapy drugs were taken with Erbitux. If these results hold up, Erbitux could become a vital part of a multidrug assault on cancer--regardless of ImClone's fate. And Mendelsohn may finally see his vision become a reality. --By Alice Park