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FDA panel wants study on AZ cancer drug

The US FDA Oncologic Drugs Advisory Committee has voted that AstraZeneca should complete a post-approval clinical trial for its investigational thyroid cancer drug, vandetanib

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee voted on Thursday that AstraZeneca (AZ) should complete a post-approval clinical trial for the company's investigational drug vandetanib, which is a potential treatment for thyroid cancer.

The 10 panel members voted unanimously that the drug, which is intended for the treatment of unresectable locally advanced or metastatic medullary thyroid cancer, should be studied in an additional trial if it is approved in order to determine whether a lower dose could potentially be effective. The lower dose might help avoid some of the serious safety issues that have been observed in clinical trials, including a possible increase in the risk of stroke, the panelists said. 

The FDA did not ask the panel members to vote on whether or not the drug should be approved, but it did ask them to discuss the product's risk-benefit profile. In that discussion, the committee members generally acknowledged that the risk-benefit profile of vandetanib is acceptable in at least some patients. 

The once-daily, oral drug was granted a priority review by the FDA, as there is currently no approved treatment in the US for advanced medullary thyroid cancer. AstraZeneca expects a decision on the US marketing application by January 7, 2011. 

Vandetanib is also under review by the European Medicines Agency (EMA). 

3rd December 2010

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