Reuters: Regulatory News: FDA staff to ask expert panel if new trial needed for Aveo drug

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FDA staff to ask expert panel if new trial needed for Aveo drug Apr 30th 2013, 13:20 Tue Apr 30, 2013 10:08am EDT * FDA staff question sends Aveo shares down as much as 21.3 pct * Staff wonder whether additional trial needed * Some analysts still believe advisory panel will be favorable By Toni Clarke April 30 (Reuters) - Staff reviewers for the U.S. Food and Drug Administration will ask a panel of outside medical experts on Thursday whether another clinical trial is needed before an experimental kidney cancer drug made by Aveo Pharmaceuticals Inc and Astellas Pharma Inc can be approved. The question caused Aveo's shares to plummet as much as 21.3 percent in early trading on Nasdaq. 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 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. The trial also showed that only 18 percent of tivozanib patients needed dosing interruptions due to side effects, compared with 35 percent for Nexavar. Patients taking tivozanib had a higher incidence of high blood pressure and fatigue, while those who received Nexavar in the study reported a higher incidence of diarrhea and hand-foot syndrome, a skin condition that resembles sunburn and can cause pain and swelling. 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 panel discussion to focus on the overall survival figures, but they nonetheless believe the panel will vote in favor of the drug given that the main goal of the trial was to show a statistically significant improvement in progression-free survival - the time before the disease worsens. "After review of the documents, we continue to believe there is a good likelihood of a favorable vote," said Geoff Meacham, an analyst at J.P. Morgan, in a research note, adding that the reviewers appear to have no new concerns on safety or efficacy. "Net-net, we would be buyers ahead of the panel," he said. 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 too believes the improved safety profile of tivozanib and the superior progression-free survival figure will lead to a favorable vote. Advanced kidney cancer is the ninth most commonly diagnosed cancer in the United States, Aveo said, with an estimated 65,000 new cases projected to be diagnosed this year. Tivozanib is a pill that is designed to block three members of the vascular endothelial growth factor (VEGF) family of proteins. Blocking VEGF acts to starve tumors of the blood supply and nutrients they need to survive. The drug is also being studied in a range of other cancers, including metastatic colorectal cancer and metastatic breast cancer. Analysts on average expect the drug to generate annual sales of $1.23 billion by 2017. In 2007, Aveo licensed the development and commercialization rights to tivozanib outside Asia from Kirin Brewery, now called Kyowa Hakko Kirin. Kyowa retained development and commercialization rights in Asia. Four years later Aveo and Astellas agreed to co-develop tivozanib outside Asia. The two companies agreed to jointly share in the costs and profits of developing the drug in North America and Europe. Outside these regions, Astellas is responsible for development and commercialization costs and will pay Aveo royalties on sales in those territories. Aveo's shares fell 19 percent to $6.02 in early trading on Nasdaq, slipping briefly as low as $5.85. Link this Share this Digg this Email Reprints

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