AstraZeneca Statement Regarding IRESSA® (gefitinib) Presentation At March FDA Advisory Board Meeting
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Mary Lynn Carver
AstraZeneca |
(302) 886-7859 |
February 1, 2005 - Wilmington, DE - After discussions with the U.S. Food and Drug Administration (FDA), AstraZeneca has agreed to take part in the regularly scheduled March 4th Oncology Drug Advisory Committee meeting. The purpose of this public session will be to share with the panel the preliminary IRESSA® (gefitinib) trial 709 data, summarize AstraZeneca’s communication activities to date to inform physicians and patients, and discuss the timelines and next steps being undertaken to fully analyze this trial.
The FDA has informed AstraZeneca that no regulatory decision or panel vote regarding IRESSA® is anticipated at the March 4th meeting as full analysis of the complete data set from this trial, including relevant biomarkers, will not have been completed. Similarly, consideration of other regulatory actions, such as removal of the drug from the market, is not anticipated until the data are fully analyzed.
The ODAC hearing agenda is subject to change at any time and will not be official until it is posted in the Federal Register one month to two weeks before the meeting. While AstraZeneca has suspended active promotion of IRESSA in the US, IRESSA remains commercially available for physicians to write prescriptions for individual patients they deem appropriate.
Physicians and patients can obtain additional information about IRESSA by calling the AstraZeneca Cancer Support Network at 1-866-99-AZCSN (1-866-992-9276).
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com
IRESSA is a registered trademark of the AstraZeneca group of companies.
