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May 5, 2008

AstraZeneca's (AZ) IRESSA still alive in Europe.....? There is life after failure in the US.

Analysis of: AstraZeneca Files Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA(TM)) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer | www.pipelinereview.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Kenneth Algazy, MD, Clinical Professor of Medicine , University of Pennsylvania School of Medicine - CCKenneth Algazy, MD 
Clinical Professor of Medicine , University of Pennsylvania School of Medicine - CC
Implications: Approval will be base on the phase III INTEREST trial that showed in NSCLC that Iressa was "non-inferior" to standard chemotherapy after platinum therapy failure first line. Iressa was better tolerated and had an improved quality of life.

Analysis: Iressa is on life support in the US but it appears potentially alive and well in the rest of the world. Tarceva (Genentech) has supplanted Iressa in the US probably related to poor trial design and dosing in the initial trials. This will give AZ life outside the US and may "leak" into the North American market it they can get around the original failure as well as Tarceva's success.


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