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AstraZeneca withdraws Iressa MAA

Executive Summary

AstraZeneca announces withdrawal of European Marketing Authorisation Application for Iressa (gefitinib) Jan. 4, following consultation with European Medicines Agency. Decision comes in wake of Iressa's failure to demonstrate a survival benefit in the Iressa Survival Evaluation in Lung cancer trial (1"The Pink Sheet" Jan. 3, 2005, p. 12). "The submission of a new MAA will be considered for Iressa in future, after evaluation of the full ISEL dataset," company says. FDA is expected to provide an update on the status of Iressa's subpart H licensure in January or February. The agency could use the next round of meetings of its Oncologic Drugs Advisory Committee tentatively scheduled for March 2-3 as a forum to discuss the oncologic's status...
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