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EC approves Dendreon's Provenge

September 18, 2013 1:01 AM UTC

The European Commission approved Provenge sipuleucel-T from Dendreon Corp. (NASDAQ:DNDN) to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC) in adults when chemotherapy is not yet clinically indicated. Provenge is approved in the U.S. to treat metastatic CRPC in patients who are asymptomatic or minimally symptomatic. The biotech's stock has taken a hit on lower-than-expected uptake of the drug since its U.S. launch in 2010. Last year, Dendreon restructured for the second time after pulling its 2011 revenue guidance for Provenge. Provenge is autologous dendritic cells loaded with a fusion protein of prostatic acid phosphatase and an immunostimulatory cytokine. ...