Australian approval for Iressa

Published: 2-May-2003


The Australian Therapeutic Goods Administration has granted approval of AstraZeneca's 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 worldwide 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 FDA and the EMEA.

Brent Vose, vp 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.

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