Iressa

AstraZeneca PLC
07 August 2002




ASTRAZENECA COMPLETES NEW DRUG APPLICATION TO THE FDA FOR IRESSA(TM) (ZD1839) TO
                        TREAT NON-SMALL CELL LUNG CANCER


AstraZeneca announced today that the final documents of the New Drug Application
(NDA), for IRESSA(TM) (ZD1839) have been submitted to the U.S. Food and Drug
Administration (FDA) completing the rolling submission for the drug that began
last summer.  All clinical data including safety and efficacy information was
provided to the agency in December.  IRESSA(TM) is being considered as a
monotherapy agent for the treatment of advanced non-small cell lung cancer
(NSCLC) after disease progression following chemotherapy.

AstraZeneca has been notified by the FDA that IRESSA(TM) is scheduled for
discussion at the oncology drug advisory committee (ODAC) meeting on September
24.

IRESSA(TM) was recently approved by the Japanese Ministry of Health, Labour and
Welfare (MHLW) for the treatment of advanced non-small cell lung cancer.
Regulatory filings are pending in other countries.  Pending FDA approval,
IRESSA(TM) is expected to launch later this year in the US.  IRESSA(TM) represents
a new class of anti-cancer drugs known as selective epidermal growth factor
receptor (EGFR) 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.
IRESSA(TM) is administered as a once daily, oral tablet.

The submission is based on two phase II trials (IDEAL 1 and 2) involving
approximately 400 patients in the US, Japan and Europe.


7 August 2002


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