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JNCI Journal of the National Cancer Institute 2004 96(20):1495-1496; doi:10.1093/jnci/96.20.1495
© 2004 by Oxford University Press
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© 2004 Oxford University Press

NEWS

Accelerated Approval Seen as Triumph and Roadblock for Cancer Drugs

Edward Susman

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

The U.S. Food and Drug Administration's accelerated drug approval process gives cancer patients faster access to the oncology drug pipeline and the chance to receive new and promising drugs.

That is the bright side of a process that has been part of the drug approval landscape for more than a decade. However, some observers suggest that there may be a dark side as well, one that could actually harm cancer patients.

The accelerated approval process came about in 1992 as a way to speed to market drugs for life-threatening diseases. Through this mechanism, drugs are approved on the basis of preliminary evidence that uses a surrogate marker to show a clinical benefit—in most cases, a surrogate for survival. For example, Gleevec (imatinib mesylate) was given accelerated approval in May 2001 based on data from three studies that used hematologic and cytogenetic response as a surrogate . . . [Full Text of this Article]

Seeking Full Approval

Suggested Reform

Better Surrogate Markers


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