AstraZeneca Withdraws Regulatory Submissions For Zactima In Combination With Chemotherapy

AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer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 FDA and EMEA. The applications were submitted to regulatory agencies in June 2009.

The company said that 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 (PFS) as the primary endpoint may not be sufficient for approval.

The phase III clinical trial results demonstrate that vandetanib is clinically active when used in combination with chemotherapy. AstraZeneca is expected to complete the ongoing phase III trial programme which will give a more complete view of vandetanib efficacy in different clinical settings.

The company added that the results from the Zephyr (300mg monotherapy study in patients with advanced NSCLC who have previously received an EGFR inhibitor) and Zeta (300 mg monotherapy in advanced medullary thyroid cancer) studies, are expected in late 2009 or early 2010.