LONDON, Sept. 23 /PRNewswire/ — AstraZeneca today announced
that the US Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) have accepted regulatory submissions for
review of the investigational drug vandetanib in the treatment of
patients with advanced medullary thyroid cancer (MTC). The FDA also
granted priority review status for the new drug application and set
a Prescription Drug User Fee Act (PDUFA) action date of 7 January
2011.
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The submissions are supported by the results from the ZETA study
evaluating the safety and efficacy of vandetanib compared to
placebo in patients with advanced MTC. AstraZeneca is consulting
with regulatory authorities on a proposed trade name.
ZETA was a Phase III, double-blind, placebo-controlled study
that randomized 331 patients with advanced MTC to oral once-daily
vandetanib 300mg or placebo. The study results were presented on 7
June 2010 at the American Society of Clinical Oncology annual
meeting in Chicago. 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
objective response rate (ORR), a secondary endpoint, was 45% versus
13% across the two groups (p<0.0001).
The most common adverse events (incidence >25%) associated
with vandetanib in the ZETA study included diarrhoea, rash, nausea,
hypertension and headache. The incidence of protocol-defined QTc
prolongation was 8%. The safety profile of vandetanib in this
study was similar to what has been previously observed in other
studies in medullary thyroid and non-small cell lung cancer.
Vandetanib targets the vascular endothe
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