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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

rom 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 diarrhea, rash, nausea, hypertension and headache. In the randomized 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.

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