FDA grants fast-track approval to AZ's Iressa

Published: 1-Jun-2003
Regulatory


AstraZeneca has been granted accelerated approval of Iressa (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% of US patients achieved tumour shrinkage of at least 50% after their disease had progressed following failure of both platinum-based and docetaxel chemotherapies.

'Today's announcement offers further hope to patients suffering from advanced non-small cell lung cancer, a devastating and life-threatening disease,' said the ceo of AstraZeneca, Sir Tom McKillop,. 'AstraZeneca is proud to have discovered Iressa and to be the first company to deliver this new class of cancer treatment.'

The drug's effectiveness is based on objective response rates, which were seen in the first eight weeks of treatment. Iressa is a once-a-day 250mg 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, including rash and diarrhoea, but these are generally mild and well-tolerated. Interstitial Lung Disease (ILD) is a known complication of lung cancer and has been observed in about 1% of patients taking Iressa.

In the US alone, 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 at least $1bn (€0.9bn) and is set to grow to $4.5bn (€4bn) in 2011.

As part of the accelerated approval 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.

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