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May 5, 2008

AstraZeneca : Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA™) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer

2 May 2008 - AstraZeneca announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA™) as a treatment for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have been pre-treated with platinum-containing chemotherapy.
The application is based on data from the Phase III INTEREST study, which showed that patients with pre-treated advanced NSCLC who received gefitinib had non-inferior overall survival to those treated with intravenous chemotherapy (docetaxel). In addition, gefitinib had a more favourable tolerability profile than docetaxel and significantly more patients receiving gefitinib had an improvement in quality of life... AstraZeneca's Press Release -