© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 24, 1825,
December 18, 2002
© 2002 Oxford University Press
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Preliminary Findings of the Oversight and Investigations Subcommittee
Selected findings from the committee’s preliminary report on the development of the drug Erbitux by ImClone Systems Inc.:• In August 2000, the primary FDA medical reviewer handling the ImClone/Erbitux matter did not believe that ImClone’s 9923 study met the criteria for accelerated approval and fast-track designation.
• FDA’s decision to grant fast-track designation to ImClone’s Erbitux appears to have been based on the wrong version of the 9923 protocol and was made before it had the single-agent data on Erbitux.
• The Bristol-Myers Squibb independent radiology review showed that strict scrutiny of the study data resulted in a response rate of only 12.5% (as opposed to the claimed 22.5% response rate) and that the number of evaluable patients was only approximately 89 (as opposed to the original 120). If these data were in fact correct, the 9923 study failed to meet the 15% clinical endpoint set by ImClone and the study would be too small to support an accelerated approval by itself.
• ImClone knew the results of the single-agent study on October 12, 2001, but its then-CEO appeared to portray these results in a positive light to the Bristol-Myers Squibb chief scientific officer.
The committee’s complete report is available at http://energycommerce.house.gov/107/hearings/06132002Hearing587/Papineau1014.htm#report
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