ARTICLE | Clinical News

Provenge sipuleucel-T regulatory update

November 22, 2010 8:00 AM UTC

CMS's Medicare Evidence Development & Coverage Advisory Committee concluded there is adequate evidence that Provenge sipuleucel-T from Dendreon significantly improves overall survival (OS) 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 OS 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." ...