© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 5, 326-328,
March 6, 2002
© 2002 Oxford University Press
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Biotech Firm Faces Challenges from FDA, Falling Stock Prices
At the American Society of Clinical Oncology’s May 2001 annual meeting, researchers presented findings on a promising new drug, Erbitux, that offered hope for patients with colorectal cancer resistant to standard chemotherapy.
The drug, made by ImClone Systems Inc., New York, generated unusual excitement among researchers, patients, and investors and was featured on 60 Minutes and on the cover of Business Week.
Nine months later, the company has seen its stock price plunge, it is under three federal investigations, and it has been called the Enron of the biotechnology industry. Patients may have to wait years to reap the drug’s benefits while the U.S. Food and Drug Administration determines whether it has any.
Oncologists familiar with Erbitux (also known as IMC-C225 and cetuximab) say they have seen it work, and most expect it will gain FDA approval eventually. But several other drug makers have competing agents in the pipeline,
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