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JNCI Journal of the National Cancer Institute 2005 97(7):473; doi:10.1093/jnci/97.7.473
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© 2005 Oxford University Press

NEWS

FDA Oncology Committee Debates Iressa's Status Following Negative Trial Results

Renee Twombly

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

Serious questions about the fate of the lung cancer drug Iressa (gefitinib) were asked last month when the U.S. Food and Drug Administration's Oncology Drugs Advisory Committee (ODAC) met for the first time since the drug's maker AstraZeneca announced that Iressa, the first targeted cancer therapy to receive accelerated approval, failed its phase III randomized, placebo-controlled confirmatory survival trial.

Because a complete analysis of the data from that 1,692-patient trial, including an examination of patient subgroups that appeared to . . . [Full Text of this Article]


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