ARTICLE | Clinical News

Provenge sipuleucel-T regulatory update

August 9, 2010 7:00 AM UTC

Dendreon said that it asked the Centers for Medicare & Medicaid Services (CMS) to reconsider whether a National Coverage Analysis is necessary for the use of Provenge sipuleucel-T to treat metastatic, castrate-resistant prostate cancer. Dendreon said there is "overwhelming clinical evidence showing a significant improvement in overall survival in this patient population." FDA approved the autologous cellular immunotherapy in April. CMS expects to complete its analysis by June 30, 2011. ...