ARTICLE | Clinical News

Provenge sipuleucel-T regulatory update

October 20, 2014 7:00 AM UTC

The U.K.'s NICE issued a preliminary appraisal recommending against Provenge sipuleucel-T from Dendreon to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC) in adults when chemotherapy is not yet clinically indicated -- its approved indication. The committee concluded that Provenge prolonged overall survival (OS) compared to placebo, but the drug did not delay disease progression. NICE also concluded that there are uncertainties about how much Provenge would cost NHS, but noted the incremental cost-effectiveness ratio (ICER) for Provenge was "well above" the range considered a cost-effective use of NHS resources. The closing date for comments is Nov. 6, with a second appraisal committee meeting scheduled for Nov. 19. ...