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Iressa Symptom Improvement Claim Needs Controlled Study

Executive Summary

A symptom improvement claim for Iressa in cancer patients would require a randomized, controlled trial, FDA's Oncologic Drugs Advisory Committee agreed Sept. 24

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Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval

AstraZeneca's first chance to secure traditional approval for Iressa will be a randomized trial assessing symptom improvement in non-small cell lung cancer due to be submitted to the agency by June 2005

Iressa Clears FDA: Phase IV Symptom Trial Will Be First Shot At Full Approval

AstraZeneca's first chance to secure traditional approval for Iressa will be a randomized trial assessing symptom improvement in non-small cell lung cancer due to be submitted to the agency by June 2005

Iressa Cross-Over Study Could Show Clinical Benefit, AZ Says; ODAC Is Wary

AstraZeneca believes a controlled, cross-over trial could be used to confirm the sympom benefit of Iressa in refractory non-small cell lung cancer patients, VP-Medical Director of Oncology George Blackledge, MD, said during FDA's Oncologic Drugs Advisory Committee Sept. 24

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