AstraZeneca PLC
09 January 2003
ASTRAZENECA ANNOUNCES FDA REQUIRES MORE TIME FOR PRIORITY REVIEW OF IRESSA(R)
(ZD1839) U.S. APPLICATION -DECISION EXPECTED BY MAY 5, 2003
The U.S. Food and Drug Administration (FDA) has notified AstraZeneca that it
requires more time to review information requested of the company during the six
month priority review of the new drug application (NDA) for IRESSA(R) (ZD1839/
gefitinib). AstraZeneca will work closely with the Agency to complete the review
in a prompt and effective manner. The extended user fee goal date is May 5th
2003.
On September 24, 2002 the Oncologic Drugs Advisory Committee (ODAC) made a clear
recommendation to the FDA supporting the approval of IRESSA(R) (ZD1839/
gefitinib). Since that time, AstraZeneca has continued to provide additional
information to the FDA as requested by the agency, including extensive safety
information on patients involved in clinical trials, the expanded access
programme (compassionate use) and clinical use in Japan where the drug is
approved.
At the urging of patients and physicians, and with the support of the FDA,
AstraZeneca continues to provide an extensive compassionate use programme for
the drug during the review period. In the past two years, almost 20,000
patients in the U.S. have received IRESSA(R) through this programme.
Lung cancer is the leading cause of cancer deaths in the United States, which
accounted for approximately 155,000 deaths in 2002. Non-small cell lung cancer
is the most common form of lung cancer, accounting for 80 per cent of all lung
cancer cases. IRESSA(R) is being considered for use in the most advanced of
these patients, who have progressed despite multiple other treatments.
Currently no treatment option exists for these patients.
9 January 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 20 7304 5034
Steve Brown, Tel: +44 (0) 20 7304 5033
Investor Relations:
Jonathan Hunt, Tel: +44 (0) 20 7304 5087
Mina Blair Robinson: Tel: +44 (0) 20 7304 5084
Notes to editors:
For more information on AstraZeneca please visit www.astrazeneca.com
This press release contains forward-looking statements with respect to
AstraZeneca's business. By their nature, forward-looking statements and
forecasts involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ materially.
For a discussion of those risks and uncertainties, please see the company's
Annual Report/Form 20-F for 2001.
IRESSA(R) is a trademark of the AstraZeneca group of companies.
-Ends-
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