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


AstraZeneca today 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.

This is the first time an Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor (EGFR-TKI) has proven non-inferiority for overall survival relative to chemotherapy in patients with pre-treated advanced NSCLC.

The INTEREST (IRESSA Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study was a randomised, open-label, parallel-group, Phase III trial evaluating survival with gefitinib versus docetaxel in 1,466 patients with locally advanced or metastatic recurrent NSCLC who had previously received platinum-based chemotherapy.
Gefitinib is currently approved in 36 countries worldwide.

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IRESSA Media Enquiries:
Carrie Deverell +44 (0) 1625 514 77

IRESSA Media Enquiries UK:
Isabelle Jouin, +44 (0) 1582 836077
Simon Moore +44 (0) 1582 836460

Corporate Media Enquiries:
Steve Brown +44 207 304 5033 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Neil McCrae +44 207 304 5045 (24 hours)

Notes To Editors
About lung cancer in the UK
In 2006 in Europe, lung cancer with an estimated 334, 800 deaths, was the most common cause of death from cancer, representing 19.7 per cent of all non skin cancers.
Each year more than 38,000 people are diagnosed with lung cancer in the UK, that’s more than 100 people every day. Overall, of all those people diagnosed with all types of lung cancer, non-small cell lung cancer and small cell lung cancer, at all stages:
only 20 per cent will live for at least one year post diagnosis.
6 per cent will live for at least five years after diagnosis
5 per cent will live for at least 10 years.
For those who are able to have surgery to remove their cancer, about 20 per cent are alive five years later.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.


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