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PROVENGE (sipuleucel-T), an autologous cellular immunotherapy, was the first FDA-approved treatment of its kind for metastatic castration-resistant prostate cancer. In pivotal Phase 3 trials, PROVENGE demonstrated a statistically significant improvement in overall survival compared to control, extending median survival by approximately 4.1 months and reducing risk of death by about 22.5%. Nearly 40,000 men have received this treatment since approval.
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