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DNDN * $4.40 --FDA approval letter possible next week--more>>
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[QUOTE]Originally posted by Livinonklendathu: [QB] FDA panel votes in favor of Dendreon cancer drug Marketwatch - March 29, 2007 5:05 PM ET SAN FRANCISCO (MarketWatch) -- A Food and Drug Administration advisory committee on Thursday found Dendreon Corp.'s experimental prostate-cancer drug, Provenge, to be safe and effective. Seattle-based Dendreon (DNDN) is asking the FDA to approve Provenge, which acts by stimulating the body's immune system, for the treatment of asymptomatic men with advanced prostate cancer who have stopped responding to hormone treatment. Though the agency isn't bound by the recommendations of its advisory committees, it typically follows them. The FDA granted the Provenge application priority-review status in mid-January, taking its review deadline to May 15. Priority review is intended for products that address unmet medical needs. [b]The advisory committee on Thursday voted 17-0 that Provenge was safe and 13-4 that it was effective.[/b] There was concern that both of the late-stage studies submitted for consideration failed their endpoints, including the first study's primary endpoint of slowing the cancer's progression, noted Celia Witten, director of the FDA's Office of Cellular Tissue and Gene Therapies division. But that study, though small, "...did show a survival difference," she said in a telephone interview after the meeting. In the study, which evaluated 127 patients, median survival of Provenge-treated patients was found to be 4.5 months longer than those who were given a placebo. [/QB][/QUOTE]
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