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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

WILMINGTON, Del., Dec. 2, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC).

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The Advisory Committee was asked to discuss whether the indication should be limited to patients with progressive, symptomatic MTC. They were also asked to comment on whether there are any other subgroups that may be appropriate for treatment with vandetanib in light of the risk-benefit profile. The Committee was not asked to vote on this issue. The Committee was asked to vote on whether, assuming there is a population in which the risk-benefit profile is acceptable, additional doses of vandetanib should be evaluated as a post-approval study requirement to determine the optimal dose. The Committee acknowledged that there are patients with MTC in which the risk-benefit profile of vandetanib was acceptable, and voted 10 to 0 in favor of a post-approval study requirement to evaluate other doses.

"Patients with advanced medullary thyroid cancer face an unmet medical need since there is no medicine approved to treat this disease. Based on the clinical trial results we have seen with vandetanib, we believe it has the potential to provide appropriate patients and their doctors with an important treatment option," said Dr. Howard Hutchinson, Chief Medical Officer, AstraZeneca. "We look forward to continuing to work with the FDA as it evaluates the Advisory Committee recommendation and completes its review of the application."

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