Dendreon announced the approval of Provenge (sipuleucel-T suspension for intravenous infusion) for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). This approval is based on three Phase 3 studies involving 737 patients submitted to FDA to support licensure. The pivotal study was the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial (D9902B), a 512-patient, multi-center, randomized, double blind, placebo-controlled study that evaluated men with asymptomatic or minimally symptomatic, metastatic CRPC. Provenge extended median survival beyond two-years, demonstrating a median improvement of 4.1 months compared to the control group (25.8 months versus 21.7 months). Overall, Provenge reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.
Provenge is the first product in a new therapeutic class known as autologous cellular immunotherapies. It is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.
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