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news.The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca's Vandetanib new drug application for review the investigational drug as a treatment for patients with advanced medullary thyroid cancer (MTC).
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The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.
The filing of the NDA was done on the basis of the positive results from the ZETA study assessing the safety and efficacy of Vandetanib compared to placebo in patients with advanced MTC.
The results of the ZETA trial suggested that treatment with Vandetanib extended progression-free survival, the primary endpoint of the study, in patients with advanced MTC.