An FDA advisory panel yesterday voted in favor of approval of Provenge, Dendreon Corp.'s prostate cancer vaccine, saying it is both safe and effective. If the FDA approves Provenge, it will become the first-ever therapeutic cancer vaccine. A decision is expected by May 15. Two late-stage studies failed their endpoints, including the primary goal of slowing the cancer's progression. But the data did show that patients taking Provenge survived 4.5 months longer than patients on a placebo. The only other drug shown to prolong the lives of prostate cancer patients is Sanofi-Aventis's Taxotere. There remains concern that patients on Provenge exhibited a higher incidence of stroke than those on a placebo. Some analysts believe the FDA will likely give the company an approvable letter and wait for the results of a larger study that should be concluded in 2010. About 232,000 men are diagnosed with prostate cancer in the U.S. annually, and about 30,000 die of it. Dendreon shares, which were halted all day yesterday, closed Wednesday at $5.22.
Sources: MarketWatch, TheStreet.com, MSNBC
Commentary: Dendreon's Provenge: 'Substantial Evidence of Efficacy' • Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints • Dendreon Corp: A Risky Proposition • Dendreon: Thinking Strategically Ahead of the FDA Review
Stocks/ETFs to watch: Dendreon Corp. (NASDAQ:DNDN). Competitors: Sanofi-Aventis [ADR] (NYSE:SNY), Biomira Inc. (OTCPK:BIOM), Cell Genesys, Inc. (CEGE)
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