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AstraZeneca Iressa approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's epidermal growth factor receptor agent Iressa (gefitinib) clears FDA May 5 "as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies." The accelerated approval is based on a 10% response rate seen in Phase II trials, which the agency said was in line with previous oncology approvals under Subpart H. The Iressa approval became controversial after the Phase III INTACT trials failed to show a benefit in survival, symptom improvement or quality of life when Iressa was added to traditional chemotherapy in treatment-naïve patients. AstraZeneca will conduct three trials to confirm Iressa's clinical benefit with survival, time to progression and symptom improvement endpoints. The drug will be available in mid-May at a wholesale price of $1,560 per mont

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