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Company withdraws drug application

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The makers of a drug used in combination with chemotherapy to treat patients with advanced lung cancer have withdrawn regulatory submissions for its use.

AstraZeneca had applied to the US Food and Drug Administration, and the European Medicines Agency for the use of its Zactima drug.

But it reversed its decision after new analysis of the drug showed it did not significantly improve chances of survival.

Early feedback from the regulatory bodies also suggested the Zactima would not be approved.

The company said in a statement to the stock market that latest trials showed the drugs was “clinically active” when used with chemotherapy.

It said: “AstraZeneca will complete the ongoing Phase III trial programme which will give a more complete view of Vandetanib efficacy in different clinical settings.”

Copyright Press Association 2009

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AstraZeneca

 



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