4th Jan 2005 14:46
AstraZeneca PLC04 January 2005 GEFITINIB (IRESSA(TM)) MARKETING AUTHORISATION APPLICATION WITHDRAWN IN EU AstraZeneca today announced that it is withdrawing the European MarketingAuthorisation Application (MAA) for IRESSA(TM) (gefitinib) in treating patientswith non-small cell lung cancer (NSCLC) from the European Medicines Agency(EMEA). The company has taken this decision after consultation with the EMEA in view ofthe IRESSA Survival Evaluation in Lung cancer (ISEL) survival results, whichwill not meet the approval requirements for the current IRESSA MAA. Thesubmission of a new MAA will be considered for IRESSA in the future, afterevaluation of the full ISEL dataset and emerging data. In the preliminary analysis of the ISEL trial, there was a statisticallysignificant improvement in tumour shrinkage (response rate) and time totreatment failure, which did not translate into a statistically significantsurvival benefit. In the meantime, AstraZeneca believes it would be prematureto close the IRESSA compassionate use (Expanded Access) programme to newpatients until the full ISEL dataset is reviewed, as the company remainsconvinced by the evidence that IRESSA provides some benefit for patients withNSCLC. The status of all ongoing AstraZeneca-sponsored studies in NSCLC isunder review. Investigator and co-operative groups have been informed, alltrials are open to recruitment and are being reviewed on a trial by trial basis.Studies in other cancer types are set to continue. Discussions with the US Food and Drug Administration (FDA), MHLW in Japan andall other Regulatory Authorities continue about the status of IRESSA. AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of over $18.8 billion and leadingpositions in sales of gastrointestinal, oncology, cardiovascular, neuroscienceand respiratory products. AstraZeneca is listed in the Dow Jones SustainabilityIndex (Global) as well as the FTSE4Good Index. 4 January 2005 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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