Friday, October 22, 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

We know that, Vandetanib (proposed trade name Zactima), also known asZD6474, is an antagonist of the vascular endothelial growth factor receptor (VEGFR) and the epidermal growth factor receptor (EGFR). It is a tyrosine kinase inhibitor. Drug has a third target: inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer and is being developed by AstraZeneca. It is a medication currently undergoin  clinical trials as a potential targeted treatment for non–small-celllung cancer.

Now 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. More...

No comments: