General Information

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.

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.

Side Effects

Adverse events associated with the use of Provenge may include, but are not limited to, the following:

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

Dosing/Administration

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 two-week intervals.

Clinical Trial Results

FDA Approval
The FDA approval of Provenge was based on three studies.
 

Study One
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).
 

Studies 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 end point was time to disease progression; analysis of the primary end point 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.