Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Nephrology | Oncology | Family Medicine | Urology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved May 2010
Treatment Area: hormone refractory prostate cancer
Dendreon is an autologous cellular immunotherapy designed to induce an immune response targeted against PAP (prostatic acid phosphatase), an antigen expressed in most prostate cancers.
Provenge is specifically indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.
Provenge is supplied as an infusion, containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, designed for intravenous administration. The recommended course of therapy is three complete doses, given at approximately 2-week intervals.
The FDA approval of Provenge was based on three studies.
This randomized, double-blind, placebo-controlled, multicenter trial enrolled 512 subjects with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The median overall survival was 25.8 months for the Provenge arm and 21.7 months for the placebo arm (p=0.032).
Study Two and Three
These were similar randomized, double-blind, placebo-controlled, multicenter trials in patients with
metastatic castrate resistant prostate cancer and no cancer-related pain. The primary
endpoint was time to disease progression; analysis of the primary endpoint did not reach
statistical significance. The median overall survival was 25.9 months for the Provenge arm and 21.4 months for the placebo arm.
Adverse events associated with the use of Provenge may include, but are not limited to, the following:
- Back pain
- Joint ache
Mechanism of Action
Dendreon is an autologous cellular immunotherapy. While the precise
mechanism of action is unknown, Provenge is designed to induce an immune response
targeted against PAP, an antigen expressed in most prostate cancers.
Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009 Aug 15;115(16):3670-9
Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2006 Jul 1;24(19):3089-94
For additional information regarding Provenge or prostate cancer, please visit the Provenge web page.