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AstraZeneca withdraws cancer drug from regulatory review

10/28/2009

LONDON AstraZeneca has withdrawn its regulatory approval application for the use of a cancer drug combined with chemotherapy in patients with a form of lung cancer because it didn’t improve patients’ odds of survival, the Anglo-Swedish drug maker announced Wednesday.

The company withdrew the application for Zactima (vandetanib) in patients with advanced non-small cell lung cancer taking chemotherapy, saying the drug did not provide an overall advantage to patients in terms of survival and that it had also received feedback from regulatory agencies that the drug may not be good enough for approval.

The company said late-stage clinical trial results showed that Zactima became active when combined with chemotherapy and that it would complete phase 3 trials to get a more complete idea of the drug’s efficacy.

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