AstraZeneca Withdraws Approval Request for Zactima

27 October 2009 (Last Updated October 27th, 2009 18:30)

AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib), a potential non-small cell lung cancer treatment, based on new information. The company withdrew its submissions for Zactima (vandetanib) 100mg in combination with chemotherapy from the US Food and D

AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib), a potential non-small cell lung cancer treatment, based on new information.

The company withdrew its submissions for Zactima (vandetanib) 100mg in combination with chemotherapy from the US Food and Drug Administration and the European Medicines Agency after the drug showed no overall survival advantage.

Vandetanib showed no overall survival advantage when added to chemotherapy and preliminary feedback from the regulatory agencies also indicated that designating progression-free survival as the primary endpoint may not be sufficient for approval.

AstraZeneca has announced that it will complete the ongoing Phase III trial programme, which is expected to give a more complete view of vandetanib’s efficacy in different clinical settings.

Results from this study are expected in late 2009 or early 2010.