Iressa

RNS Number:7169K
AstraZeneca PLC
06 May 2003



  ASTRAZENECA RECEIVES FDA APPROVAL FOR NEW CANCER DRUG IRESSA(TM)(gefitinib,
                                    ZD1839)


   IRESSA is the First in a New Class of Drugs for the Treatment of Advanced

  Non-Small Cell Lung Cancer-Only FDA-Approved Option for Third Line Patients

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AstraZeneca PLC announced today that the US Food and Drug Administration (FDA)
has granted accelerated approval of IRESSA(TM)(gefitinib, ZD1839) for the
treatment of advanced non-small-cell lung cancer (NSCLC). The FDA approval is
based upon data from Phase II trials showing 13.6 per cent of US patients
achieved tumour shrinkage of at least 50 per cent, after their disease had
progressed following failure of both platinum-based and docetaxel
chemotherapies.

The effectiveness of IRESSA is based on objective response rates. Most responses
were seen in the first eight weeks of treatment. IRESSA is a once-a-day 250 mg
pill and is not typically associated with the severe side-effects often seen
with standard cytotoxic chemotherapy treatments used to treat NSCLC patients.
Most patients experience some side-effects but these are generally mild and
well-tolerated including rash and diarrhoea. Interstitial Lung Disease (ILD) is
a known complication of lung cancer and has been observed in about 1 per cent of
patients taking IRESSA.


The US approval reflects a recognition of the need for new treatment options for
NSCLC - a complex, severely symptomatic illness with a devastating impact on
patients and their families. Lung cancer is the biggest cancer killer in the
world, causing more deaths each year than breast, prostate and bowel cancer put
together. NSCLC is the most common form, accounting for 80 per cent of cases. In
the year 2000 there were over 1.2 million people diagnosed with lung cancer
world-wide and more than 1 million people died from the disease. In the United
States, lung cancer will account for approximately 157,000 deaths in 2003. The
total market for drugs used to treat non-small cell lung cancer in the US is
estimated to be worth over US $1 billion and is set to grow to US $4.5 billion
in 2011.

The FDA accelerated (or sub part H) approval process was created for life
threatening conditions where a new drug provides meaningful therapeutic benefit
over available treatments, or in the case of IRESSA, where no approved therapies
exist. As part of this process, AstraZeneca has agreed with FDA that it will
complete a programme of Phase IV clinical studies, which are designed to further
demonstrate the clinical benefits of IRESSA and satisfy FDA requirements for
full approval.

IRESSA was approved for the treatment of inoperable or recurrent NSCLC in Japan
in July 2002 and has recorded US $86 million in sales since its launch. The
drug's approval was also announced in Australia on May 1st 2003. A marketing
application was submitted in the European Union in February 2003. Marketing
applications have also been submitted in 12 other countries with a number of
these nearing completion of the review process. Additional marketing
applications are planned for submission in the near future. Phase II clinical
trials are also underway in other solid tumour types including colorectal,
breast, head and neck and prostate cancers.

IRESSA(TM) is a trademark of the AstraZeneca group of companies.

For a copy of the US IRESSA product label, please visit: www.astrazeneca.com.


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Media Inquiries:

Steve Brown, [phone]

Emily Denney, [phone]

Out of Hours: [phone]

Analyst Inquiries:

Jonathan Hunt, [phone]

Mina Blair-Robinson, [phone]




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