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Re: jbog post# 79019

Wednesday, 10/28/2009 8:48:08 AM

Wednesday, October 28, 2009 8:48:08 AM

Post# of 252474
AstraZeneca pulls Zactima combination submission

LONDON (MarketWatch) -- Drugmaker AstraZeneca (LSE:UK:AZN) (NYSE:AZN) siad Wednesday that it has withdrawn the regulatory submissions for the use of its Zactima 100mg drug in combination with chemotherapy in patients with advanced non-small cell lung cancer. The application was withdrawn from the U.S. FDA and the European Medicines Agency, having been submitted in June. The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival as the primary endpoint may not be sufficient for approval, the firm said.

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