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.