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Iressa® (gefitinib) 250 mg Tablets Fail to Demonstrate Non-inferiority in Overall Survival Versus Docetaxel OTTAWA, CANADA -- October 11, 2007 -- Health Canada has sent a letter to health care professional involved in the Iressa Patient Registry (IPR), to inform them of the key results from an Iressa study. The study, conducted in Japan, is entitled: "A multicentre, randomised, open-label, parallel- group, phase III post-marketing clinical study to compare the overall survival between Iressa (gefitinib) and docetaxel in patients with advanced or metastatic (Stage IIIB/IV), or recurrent Non-Small Cell Lung Cancer, who failed one or two chemotherapy regimens." The following key points were communicated to Health Canada: · The study failed the primary objective to demonstrate non-inferiority of Iressa to docetaxel in overall survival: HR 1.12, 95.24% CI 0.89 to 1.40. · When compared to docetaxel, some secondary endpoints (response rate, time to treatment failure, and quality of life) showed benefit with Iressa use, but other secondary endpoints did not (progression free survival, disease control rate, and disease-related symptoms). · No new safety findings were noted. · There were 3 treatment-related deaths due to interstitial lung disease (ILD) in the Iressa arm and none in the docetaxel arm. No patients in Canada should receive Iressa unless they are enrolled in the IPR. Health Canada, in collaboration with AstraZeneca supports the IPR to allow those patients who were benefiting from Iressa as of December 31, 2006 to continue in the program as long as they continue to benefit. Please discuss this information with your IPR patients. You may need to reconsider the risk/benefit profile of Iressa for your patients. Adverse Event Reporting: Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients receiving Iressa should be reported to AstraZeneca Canada Inc., or Health Canada, at the following addresses: AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 Tel: 1-800-433-0733 Fax: 1-800-267-5743 www.astrazeneca.ca Any suspected adverse reaction can also be reported to: Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C OTTAWA, Ontario, K1A 0K9 Tel: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 866-234-2345 Fax: 866-678-6789 cadrmp@hc-sc.gc.ca Any questions or require additional information regarding Iressa® should be addressed to AstraZeneca Medical Information at 1-800-668-6000 (English) and/or 1-800-461-3787 (French). Iressa® and the AstraZeneca logo are trademarks of the AstraZeneca group of companies. SOURCE: Health Canada E-mail this page to a friend or colleague! To print, use this version