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Fate Of AstraZeneca's Iressa To Be Discussed By Advisory Cmte. March 4

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will seek input from its Oncologic Drugs Advisory Committee on whether Iressa's accelerated approval should be withdrawn after the non-small cell lung cancer agent failed to show a survival benefit in a confirmatory trial.

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AstraZeneca Seeks Cmte. Input On Further Iressa Marketing Steps

AstraZeneca publishing "Dear Doctor" letter on failed survival study results in oncology journals for foreseeable future. Efforts to inform physicians of trial results have led to a "substantial reduction" in new prescriptions for gefitinib, company says.

AstraZeneca Seeks Cmte. Input On Further Iressa Marketing Steps

AstraZeneca publishing "Dear Doctor" letter on failed survival study results in oncology journals for foreseeable future. Efforts to inform physicians of trial results have led to a "substantial reduction" in new prescriptions for gefitinib, company says.

Iressa Advisory Committee Will Not Vote On Oncologic’s Status – AstraZeneca

FDA will not make a regulatory decision on Iressa until survival study data have been fully analyzed, AstraZeneca says; the company expects to complete its data analysis by July. AstraZeneca will present “top-line” data from the ISEL survival study at the March 4 Oncologic Drugs Advisory Committee meeting.

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