From: global-distribution@prnewswire.co.uk
Sent: 02 May 2008 14:30
To: Helen Moore
Subject: ASTRAZENECA FILES MARKETING APPLICATION IN EUROPE FOR EGFR INHIBITOR GEFITINIB (IRESSATM) IN LOCALLY ADVANCED PRE-TREATED NON-SMALL CELL LUNG CANCER (NSCLC)

NOT FOR DISTRIBUTION IN THE UNITED STATES

 

ASTRAZENECA FILES MARKETING APPLICATION IN EUROPE FOR EGFR INHIBITOR GEFITINIB (IRESSATM) IN LOCALLY ADVANCED PRE-TREATED NON-SMALL CELL LUNG CANCER (NSCLC)

 

Alderley Park, UK, 2 May 2008 - AstraZeneca today announced the

submission of a marketing authorisation application to the European Medicines

Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSATM) as a

treatment for patients with pre-treated locally advanced or metastatic NSCLC.

 

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 equivalent (non-inferior1) overall survival to those treated with

intravenous chemotherapy (docetaxel).(1) 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.

 

- ends -

 

Notes to editors

 

About lung cancer

 

- Over 1.35 million new cases of lung cancer are diagnosed every year and

nearly 1.2 million people die as a result of this devastating disease - more

than breast, colon and prostate cancer combined.(2)

 

- If lung cancer is detected at early stages, before it has spread to

other organs or lymph nodes, around half of patients can survive for five

years or more. However, few lung cancers are found at this early stage and it

is normally diagnosed at the advanced stage, when five year survival falls to

approximately 15%.(3)

 

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.

 

- For more information about AstraZeneca, please visit:

http://www.astrazeneca.com

 

For further information, please contact:

 

Carrie Deverell

AstraZeneca

Tel: +44 (0) 1625 514 77

Mobile: +44 (0) 7929 845 108

carrie.deverell@astrazeneca.com

 

Reference List

 

(1) Douillard, J-Y. et al, Gefitinib (IRESSA) versus

docetaxel in patients with locally advanced or metastatic non-small-cell lung

cancer pre-treated with platinum-based chemotherapy: a randomized, open-label

Phase III study (INTEREST). Eur J Cancer Suppl 2007; 5(6): 2, abs 2LB

 

(2) Ferlay, J. Bray P. Pisani, P. Parkin, DM. GLOBOCAN

2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase

No. 5. version 2.0. Lyon: IARC Press, 2004.

 

(3) Bepler G. Lung cancer epidemiology and genetics. J

Thorac Imaging 1999; 14(4):228-234.

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