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Iressa filed in Europe amid safety concerns

Published on 24/10/03 at 04:58pm

AstraZeneca has submitted its lung cancer drug Iressa for approval in Europe, despite concerns about side-effects.

The novel drug was launched in Japan, its first market, last July and has now been linked to at least 173 deaths out of a total of 473 patients who developed lung disorders including interstitial pneumonia.

But the drug's use as a last chance treatment for terminally ill patients with inoperable non-small cell lung cancer (NSCLC) means its risk/benefit profile remains sound, and is unlikely to be withdrawn.

Japan's Ministry of Health has, however, imposed restrictions on Iressa since December, a move that Martin Wright, President of AstraZeneca's Japanese subsidiary, says has resulted in a reduced number of side-effects.

AstraZeneca's clinical trial data show 40% of patients experienced tumour shrinkage and disease stabilisation, with a third of patients in one study with a very poor prognosis still alive one year after starting therapy.

The company will now run an additional 5,000 patient clinical study in Japan as it awaits US approval for the drug, expected in the first half of 2003.

The EU application follows the EMEA submission on 5 February of another AstraZeneca product, Faslodex, for advanced breast cancer in postmenopausal women whose disease has progressed following prior endocrine therapy.

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