Astrazeneca Withdraws Regulatory Submissions for Cancer Drug

AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer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 to regulatory agencies 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. It was also based on preliminary feedback from regulatory agencies that the current package with Progression-Free Survival (PFS) 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 program which will give a more complete view of vandetanib efficacy in different clinical settings.