Iressa

AstraZeneca PLC
25 September 2002






FDA ADVISORY COMMITTEE VOTES IN FAVOUR OF ACCELERATED APPROVAL OF ASTRAZENECA'S
           IRESSA(R) (ZD1839) FOR ADVANCED NON-SMALL-CELL LUNG CANCER



AstraZeneca announced today that the Oncology Drugs Advisory Committee (ODAC) to
the U.S. Food and Drug Administration (FDA) voted 11 to 3 that results in third
line advanced non-small-cell lung cancer (NSCLC) were 'reasonably likely to
predict clinical benefit,' which the FDA indicated was a vote for accelerated
approval for Iressa(R) (ZD1839) for the treatment of advanced NSCLC after
disease progression following at least two chemotherapy agents (third line).
The FDA will now review the ODAC recommendation and make their final
determination regarding granting accelerated approval for 'Iressa'.  There are
currently no approved drugs for this setting.  Lung cancer is the leading cause
of cancer deaths in the United States, and NSCLC accounts for 80 percent of all
lung cancer cases.


'There is a critical unmet need for new lung cancer treatment, and 'Iressa'
provides a targeted new approach in the treatment of the disease,' said Gerard
T. Kennealey, MD, Vice President of Oncology Clinical Research, AstraZeneca.  '
The ODAC deliberations were a vote of confidence in 'Iressa' and the clinical
benefit we have seen with this drug.'



The regulatory package for 'Iressa' currently before the FDA is intended to
fulfill the requirements for 'accelerated approval' commonly referred to as
sub-part H approval, which allows for early approval of promising drugs for
diseases that are serious or life-threatening, where the new drug appears to
provide benefit over available therapy.   Accelerated approval can be granted on
the basis of a surrogate endpoint, like tumor response, that is reasonably
likely to predict clinical benefit and must be followed up with additional
studies after the drug is approved.







                                                                        cont....



                                      -2-



If approved by the FDA, 'Iressa' will be the first drug available in the US from
a new class of anti-cancer drugs known as selective epidermal growth factor
receptor-tyrosine kinase (EGFR-TK) inhibitors that target and block, within the
cell, signaling pathways that are implicated in the growth and survival of
cancer cells. These pathways appear to play a major role in the growth of many
solid tumors.  If approved, 'Iressa' will be sold as a once daily, 250mg oral
tablet.

'Iressa' was approved on July 5, 2002, by the Japanese Ministry of Health,
Labour and Welfare (MHLW) for the treatment of advanced NSCLC, and regulatory
filings are pending in other countries.



AstraZeneca currently has a global Expanded Access Programme (EAP) for 'Iressa'.
  This programme was instituted to provide 'Iressa' to NSCLC patients who do not
qualify for clinical trials and who have exhausted other treatment options.  To
date, over 18,000 patients have received 'Iressa' through this compassionate use
programme, the vast majority in the United States.



'Iressa' is a trademark, the property of the AstraZeneca group of companies.



                                     -Ends-

September 25, 2002



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