Download Second Approval for Novel Anti-cancer Treatment

news release
May 2, 2003
ASTRAZENECA RECEIVES AUSTRALIAN APPROVAL FOR IRESSA™
FOR ADVANCED NON-SMALL CELL LUNG CANCER
Second Approval for Novel Anti-cancer Treatment
AstraZeneca announced today that the Australian Therapeutic Goods Administration
has granted approval of IRESSA™ (gefitinib, ZD1839) for the treatment of patients
with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have
previously received treatment with chemotherapy. The decision in Australia
represents the second approval world-wide for IRESSA— the first in a new class of
anti-cancer drugs known as ‘Epidermal Growth Factor Receptor (EGFR) inhibitors’.
IRESSA was approved by the Japanese Ministry of Health, Labour and Welfare for
the treatment of inoperable or recurrent NSCLC in July 2002 and is under review
elsewhere, including the US Food and Drug Administration and the European
Medicines Evaluation Agency.
Brent Vose, Vice President and Head of Oncology at AstraZeneca commented,
"The approval of IRESSA in Australia offers great hope to thousands of lung cancer
patients and their families. Australia is the second country to approve IRESSA, and
we look forward to a similar outcome in a number of other countries, where
regulatory reviews are underway, so that this important new treatment can be made
available to the patients who suffer from the devastating results of advanced lung
cancer.”
The approval in Australia reflects both confidence in IRESSA and a recognition of
the critical need for new treatment options for NSCLC ― a complex, severely
symptomatic illness with a devastating impact on the patient and their family. 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 region of South-East
Asia, there were over 65,000 new cases (of which 8,157 were reported in Australia)
and 60,599 deaths (6,938 in Australia) from lung cancer. The worldwide market for
NSCLC is valued at $1.6 billion, and is forecasted to grow to $8 billion by 2011.
The approval in Australia is based on data from two large, randomised Phase II
trials, IDEAL 1 and IDEAL 2 (IRESSA Dose Evaluation in Advance Lung Cancer).
These studies demonstrated that taking one tablet of IRESSA 250mg per day
monotherapy provided clinically-significant anti-tumour activity in patients with
previously treated advanced NSCLC.
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VAT No SE556011748201
news release
May 2, 2003
The effectiveness of IRESSA is based on objective response rates. Most responses
were seen in the first eight weeks of treatment and at least 40 per cent of patients
gained clinical benefit and improvement in their disease-related symptoms.
Approximately 30 per cent of patients taking IRESSA were alive after one year of
commencing 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 patients taking IRESSA in about 1 per cent of patients.
Media Enquiries:
Staffan Ternby, 070-557 43 00
Emily Denney, +44 (0) 207 304 5034
Louise Marland, Global PR Manager, Oncology
+44 (0) 1625 510782
Mobile: +44 (0) 7900 607794
Investor Relations:
Staffan Ternby, 070-557 43 00
Mina Blair Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
Notes to editors:
IRESSA™ is a trademark of the AstraZeneca group of companies.
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For further information on the Epidermal Growth Factor Receptor and its
potential role in cancer treatment, please visit www.EGFR-INFO.com
For further information on IRESSA™ and lung cancer, please visit
www.iressa.com
For further press information regarding IRESSA™ and other AstraZeneca
cancer therapies, please visit www.cancerpressoffice.com and
www.astrazenecapressoffice.com
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