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Lung cancer drug applications withdrawn

AstraZeneca has withdrawn regulatory submissions for the use of Zactima in patients with advanced non-small cell lung cancer

AstraZeneca has withdrawn regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). The applications were submitted in June 2009.

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.

Phase III clinical trial results demonstrate that vandetanib is clinically active when used in combination with chemotherapy. AstraZeneca will complete the ongoing phase III trial programme, which will give a more complete view of vandetanib efficacy in different clinical settings. Results from the ZEPHYR (300mg monotherapy study in patients with advanced NSCLC who have previously received an epidermal growth factor receptor inhibitor) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer) studies are expected in late 2009 or early 2010.

28th October 2009

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