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GEN News Highlights : Apr 7, 2011

FDA Sanctions AstraZeneca’s Medullary Thyroid Cancer Drug Vandetanib

Phase III study demonstrated that vandetanib significantly boosts PFS in unresectable or metastastic disease.

FDA has approved AstraZeneca’s kinase inhibitor vandetanib for the treatment of unresectable or metastatic medullary thyroid cancer. Clearance was based on data from the Phase III placebo-controlled Zeta trial in 331 patients, which showed that in comparison with placebo, vandetanib therapy boosted progression-free survival from 16.4 months to at least 22.6 months.

“Vandetanib is the only medicine to receive FDA approval specifically for use in patients with advanced medullary thyroid cancer, and is the first treatment that AstraZeneca has developed and brought to market under orphan drug designation in the U.S.,” notes Howard Hutchinson, AstraZeneca CMO.

Vandetanib is a VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity. A regulatory submission in the European Union for the medullary thyroid cancer indication was accepted for review in September 2010. In the U.S., the drug will be launched with a Risk Evaluation and Mitigation Strategy as its use can affect the electrical activity of the heart, AstraZeneca notes.