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US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Date:12/2/2010

mittee, part of the FDA's evaluation of the New Drug Application submitted for vandetanib, is based on the results of ZETA, the Phase III, double-blind, placebo-controlled study. The ZETA study was designed to evaluate the safety and efficacy of vandetanib compared to placebo in patients with unresectable locally advanced or metastatic MTC. MTC accounts for four percent of all thyroid cancers, and the American Cancer Society estimates that more than 44,000 new cases of thyroid cancer will be diagnosed in the United States in 2010.

AstraZeneca filed the US regulatory submission for vandetanib in the second half of 2010. The FDA granted priority review status for the NDA and set a Prescription Drug User Fee Act (PDUFA) action date of January 7, 2011. AstraZeneca is consulting with regulatory authorities on a proposed trade name. Vandetanib is also currently under regulatory review by the European Medicines Agency (EMA).

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.

About MTC

The American Cancer Society estimates that more than 44,000 new cases of thyroid cancer will be diagnosed in the United States in 2010. MTC accounts for four percent of all thyroid cancers. There are currently no approved treatment options for patients with advanced MTC.

The five-year survival rates in patients with MTC that has spread to nearby organs (Stage III) and other parts of the body (Stage IV) are 81% and 28%, respectively.

About the ZETA study

ZETA was a Phase III, double-blind, placebo-controlled study that randomized 331 patients with unresectable locally advanced or metastatic MTC to oral, once-daily vandetanib 300mg or placebo. Results f
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SOURCE AstraZeneca
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