Recommendations of the Advisory Committee of the FDA’s New Drug Application for vandetanib in advanced medullary thyroid carcinoma

The Advisory Committee was invited to discuss whether the indication should be restricted to patients with progressive, symptomatic MTC. They also asked to comment on whether there are other subgroups that may be suitable for treatment with vandetanib in the light of the benefit-risk profile. The Committee was not asked to vote on this issue. The Committee recognized that there are patients with MTC in which the benefit-risk profile of vandetanib was acceptable, and voted 10-0 in favor of a requirement for post-approval study to evaluate other doses.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 % of all thyroid cancers. There are currently no approved treatment options for patients with MTC.

AstraZeneca has presented the United States for regulatory submission vandetanib in the second half of 2010. AstraZeneca is in consultation with regulators on a proposed trade name. Vandetanib is also under regulatory review of the European Medicines Agency .

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The FDA often organizes meetings of the advisory committee to obtain independent advice and recommendations on clinical issues. While the FDA is not bound to follow this guide, the agency takes this opinion into consideration when rendering its final decisions on pending applications and other public health problems.

Patients with advanced cancer of the thyroid do a spinal unmet medical need as there are no approved drugs for the treatment of this disease. Based on the results of clinical trials we have seen with vandetanib, we think he has the potential to provide patients and their physicians with the appropriate an important treatment option, said Dr. Howard Hutchinson, Chief Medical Officer at AstraZeneca. We look forward to continue working with the FDA recommendation of the Advisory Committee evaluates and concludes his review of the application

ZETA is a Phase III double-blind, placebo-controlled trial that randomized 331 patients with unresectable locally advanced or metastatic MTC with vandetanib 300 mg orally twice daily or placebo. The results demonstrated that treatment with ZETA vandetanib significantly extended progression-free survival, the primary endpoint of the study, patients with MTC.46, p = 0.0001). The incidence of QTc vandetanib protocol defined in the arm was 8 percent versus 0 percent for placebo. The most common adverse events associated with vandetanib ZETA included in the study, rash, nausea e. In the randomization phase of the study ZETA, 12 percent of patients discontinued because of an adverse event vandetanib, compared to 3 percent of patients treated with placebo.

The safety profile of vandetanib in this study was similar to what was previously observed in other studies vandetanib medullary thyroid and non-small cell.