AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers

Reference code :: wf5390
Published date :: 02 May 2008
Expired date :: 18 September 2035

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)