Regulatory Application-Iressa

AstraZeneca PLC
28 December 2001




    AstraZeneca submits clinical data for IRESSA (ZD1839) - a new class of
                      anti-cancer treatment - in the USA



AstraZeneca today announced that it has submitted a clinical data package to
the U.S. Food and Drug Administration (FDA) in support of IRESSA (ZD1839) as
monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC)
in patients who have failed on previous chemotherapy regimens. IRESSA has been
granted fast track review by the US authorities for this indication.



Submission of data to the Japanese Ministry of Health, Labour and Welfare
(MHLW) supporting use of IRESSA for the treatment of NSCLC is scheduled to
take place early in 2002.  AstraZeneca expects to launch the treatment from
the middle of next year (2002).



NSCLC is a devastating disease where the majority of patients are diagnosed
with advanced or metastatic disease. Chemotherapy is currently the only
systemic treatment available. When approved, IRESSA will offer an additional
treatment option for patients with NSCLC, and survival data of IRESSA in
combination with chemotherapy are expected to be presented next year.



The clinical packages are based on data from two phase II trials involving
over 400 patients worldwide, which demonstrated that IRESSA at a dose of 250
mg/day leads to objective response or disease stabilisation in previously
treated patients with advanced non-small cell lung cancer (NSCLC), and is
generally well tolerated. In many patients, treatment with IRESSA also
produced rapid and prolonged relief of disease-related symptoms including
patient-reported shortness of breath, coughing and chest tightness.  In the
majority, this improvement was reported within the first one to two weeks of
treatment.



Lung cancer is becoming more prevalent.  In 2000, there were an estimated
162,100 lung cancer deaths in the US alone.  The five-year relative survival
rate for all stages of lung cancer combined is only 15 per cent.  The
worldwide market for medicines to treat lung cancer is currently worth
approximately $1.6 billion, the majority of which is accounted for by NSCLC.
In Japan, the MHLW is forecasting an 80 per cent increase in the incidence of
lung cancer in the next 15 years.



IRESSA is the first in a new class of anti-cancer drugs known as small
molecule, selective EGFR-TKIs (epidermal growth factor receptor-tyrosine
kinase inhibitors). IRESSA has a mode of action distinct from cytotoxic
chemotherapies, and is administered as a once daily, oral tablet.



IRESSA targets and blocks, within the cell, signalling 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 tumours; therefore IRESSA may
have therapeutic potential in a broad range of common cancers. IRESSA is in
Phase II clinical trials in a variety of tumours including breast, colorectal,
gastric and hormone refractory prostate cancers.







Date: 28 December 2001



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