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AstraZeneca Iressa

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's Iressa (gefitinib) is slated for review by FDA's Oncologic Drugs Advisory Committee Sept. 24. A rolling NDA for use of the epidermal growth factor receptor/tyrosine kinase inhibitor for treatment of non-small cell lung cancer was completed Aug. 5. The NDA contains two Phase II monotherapy studies in approximately 400 patients to support efficacy. Recent data from the Phase III INTACT 1 and 2 mortality trials, which examined Iressa in combination with standard platinum-based chemotherapy, failed to show a benefit in survival or symptom improvement. In announcing the results, the firm indicated that FDA could change the agenda for the Sept. 24 ODAC meeting. AstraZeneca plans to focus future studies on monotherapy use in sequential therapy regimens, with initial studies in the neoadjuvant settin

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