FDA extends review timeline for vandetanib NDA

Earlier, on 23 September 2010, the FDA and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC).

As part of the review process, the FDA required that AstraZeneca submit a Risk Evaluation and Mitigation Strategy (REMS).

The 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 expects continue to work closely with the FDA to support the review of the vandetanib NDA.