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JNCI Journal of the National Cancer Institute 2002 94(24):1824-1825; doi:10.1093/jnci/94.24.1824
© 2002 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 94, No. 24, 1824-1825, December 18, 2002
© 2002 Oxford University Press

NEWS

Erbitux Trial Flawed From the Beginning, Committee Finds

Judith Randal

The first 10% of the full text of this article appears below.

Until late last year, accelerated U.S. Food and Drug Administration approval of Erbitux for the treatment of advanced colorectal cancer seemed to be in the bag. In hindsight, however, the chances of that may have been remote.

Erbitux is made by ImClone Systems Inc., a small New York City biotechnology firm. On December 28, the FDA told the company that the drug would not get fast track approval because the application the firm had submitted to the agency for that purpose did not contain the requisite information. ImClone initially painted the refusal as the result of easily solved minor problems, thus suggesting that the approval—previously portrayed by the firm as imminent—would be only briefly delayed. (See News, March 6, p. 326.)

Also a factor in the Erbitux story . . . [Full Text of this Article]


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