FDA staff to ask expert panel if new trial needed for Aveo drug

By Toni Clarke

(Reuters) - Staff reviewers for the Food and Drug Administration will ask a panel of outside medical experts if another clinical trial is needed before an experimental kidney cancer drug made by Aveo Pharmaceuticals Inc and Astellas Pharma Inc can be approved.

In documents posted on Tuesday on the FDA's website, the reviewers said that in a late-stage trial, patients taking the drug, tivozanib, did not live longer than those who took a rival product. They asked whether a new trial was needed to better assess risk versus benefit, given that other treatments are available.

The panel of outside experts is to meet on Thursday. It will discuss the drug, designed to treat patients with advanced renal cell cancer, and advise the FDA on whether it should be approved.

A clinical trial of 517 patients showed that tivozanib delayed worsening of the disease by an average of 11.9 months compared with 9.1 months for Nexavar, a drug known generically as sorafenib that is made by Bayer AG and Onyx Pharmaceuticals. The result met the main goal of the trial.

In patients who had not previously received a similar therapy, tivozanib delayed worsening of disease by an average of 12.7 months.

Still, patients taking tivozanib did not, on average, live longer than those taking Nexavar. On average, patients in the tivozanib arm of the trial lived 28.8 months while patients taking sorafenib lived on average 29.3 months.

Investment analysts expect the expert panel to focus on the overall survival figures, although the main goal of the trial was to show a statistically significant improvement in progression-free survival - the time before the disease worsens.

John Sonnier, an analyst at William Blair & Co, said in a research note on Monday that while a focus on overall survival benefit may raise concerns with investors, he believes the improved safety profile of tivozanib and the superior progression-free survival figure will cause the expert panel to vote in favor of approval.

(Reporting By Toni Clarke in Washington; editing by John Wallace)

Source: http://news.yahoo.com/fda-staff-ask-expert-panel-trial-needed-aveo-133251409.html

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