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© 2005 Oxford University Press
NEWS |
Failing Survival Advantage in Crucial Trial, Future of Iressa Is in Jeopardy
| The first 10% of the full text of this article appears below. |
AstraZeneca announced December 17 that its drug Iressa (gefitinib) failed to show a survival advantage in the confirmatory trials needed to receive full approval from the U.S. Food and Drug Administration. Iressa was the first selective epidermal growth factor receptor (EGFR) inhibitor to receive accelerated approval, which was based not on a survival advantage but on preliminary data from a phase II study and on dramatic patient testimony.
The setback surprised and disappointed many in the research community. Many scientists and patients would like to see the drug succeed, especially in light of research reported in both Science magazine and the New England Journal of Medicine in April 2003— after the confirmatory trial of Iressa began—that found the precise target for Iressa, a targeted therapy approved to treat advanced non–small-cell lung cancer (NSCLC). These studies,
A Surprising Difference
FDA Doing Its Job
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