AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

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).

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."

The review by the Advisory Committee, 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.