Caprelsa

Treatment for Thyroid Cancer

Update: Vandetanib Now FDA Approved - April 6, 2011

US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer

WILMINGTON, Del., December 02, 2010, 2010 /PRNewswire/ -- AstraZeneca 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 favour 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 NDA 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 per cent of all thyroid cancers, and the American Cancer Society (ACS) estimates that more than 44,000 new cases of thyroid cancer will be diagnosed in the US 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 7 January 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 ACS estimates that more than 44,000 new cases of thyroid cancer will be diagnosed in the US in 2010. MTC accounts for 4% 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 randomised 331 patients with unresectable locally advanced or metastatic MTC to oral, once-daily vandetanib 300mg or placebo. Results from ZETA showed that treatment with vandetanib significantly extended progression-free survival, the primary endpoint of the study, in patients with advanced MTC. In ZETA, vandetanib demonstrated a 54% reduction in the rate of progression compared to placebo (HR=0.46, p=0.0001). The incidence of protocol-defined QTc prolongation in the vandetanib arm was 8% compared to 0% for placebo. The most common adverse events (incidence >25%) associated with vandetanib in the ZETA study included diarrhoea, rash, nausea, hypertension and headache. In the randomised phase of the ZETA study, 12% of vandetanib patients discontinued due to an adverse event compared to 3% of placebo patients. The safety profile of vandetanib in this study was similar to what has been previously observed in other studies of vandetanib in medullary thyroid and non-small cell lung cancer.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and
infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com.

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Posted: December 2010

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