The approval allows Dendreon to improve the availability of PROVENGE (sipuleucel-T) across the US.
With this approval, the total number of workstations available to manufacture PROVENGE becomes 84.
The company anticipates to continue to offer additional capacity through the anticipated licensure mid-year of one more manufacturing facility in the US.
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
In a pivotal, 512-patient Phase 3 IMPACT study PROVENGE demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC).
That trial showed PROVENGE extended median survival by 4.1 months compared to control.
Results from the similarly designed Phase 3 Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.