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CMS's Provenge questions focus on efficacy

September 28, 2010 12:03 AM UTC

CMS included several efficacy-related questions in its draft questions posted ahead of a Nov. 17 meeting to discuss prostate cancer therapy Provenge sipuleucel-T from Dendreon Corp. (NASDAQ:DNDN). The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will be asked to rate its confidence that there is adequate evidence of Provenge's efficacy, including significant improvements in overall survival, control of disease-related symptoms and avoidance or minimization of burdens associated with anti-cancer therapy in both the labeled and unlabeled indications. CMS also will ask the committee to provide input on what clinical trial designs would be needed to fill any identified evidence gaps for the immunotherapy. ...