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CMS panel backs on-label Provenge

November 18, 2010 1:39 AM UTC

CMS's Medicare Evidence Development & Coverage Advisory Committee concluded on Wednesday there is adequate evidence that Provenge sipuleucel-T from Dendreon Corp. (NASDAQ:DNDN) significantly improves overall survival in prostate cancer patients who meet the autologous cellular immunotherapy's FDA-approved indication. Provenge is approved for metastatic, castrate-resistant prostate cancer in patients who are asymptomatic or minimally symptomatic.

For the overall survival endpoint, the average vote among voting committee members was 3.6 on a scale of 1-5, where 1 is "low confidence," 3 is "intermediate confidence," and 5 is "high confidence." The average committee vote was 3.1 on a question about the committee's confidence that there is adequate evidence to conclude that Provenge "significantly improves the avoidance of the treatment burdens (e.g., access, delivery, or side-effects) associated with anticancer therapy." ...