FDA extend review timeline for vandetanib new drug application

AstraZeneca announced that the US Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for the investigational drug vandetanib.


As part of the review process, the FDA required that AstraZeneca submit a Risk Evaluation and Mitigation Strategy (REMS). A proposed REMS was submitted by AstraZeneca and the FDA accordingly extended the Prescription Drug User Fee Act (PDUFA) date from 7 January 2011 to 7 April 2011.

AstraZeneca is seeking approval of vandetanib for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC). Overall, MTC accounts for about four per cent of all thyroid cancers, and the American Cancer Society estimates that more than 44,000 new cases of thyroid cancer were diagnosed in the US in 2010.