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AstraZeneca Withdraws Zactima Submissions

AstraZeneca withdrew its regulatory submissions Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the FDA and the EMEA. The applications were submitted in June 2009.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AstraZeneca withdrew its regulatory submissions Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the FDA and the EMEA. The applications were submitted in June 2009.

The decision was based on 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 (PFS) as the primary endpoint might not be sufficient for approval.

The company will complete its ongoing Phase III trial program to assess Zactima’s efficacy in different clinical settings.

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