Provenge

Provenge, the brand name for sipuleucel-T, is an autologous cellular immunotherapy used in the treatment of certain advanced forms of prostate cancer. It is indicated for men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or have only minimal symptoms. It received approval from the U.S. Food and Drug Administration in 2010.

Mechanism: The therapy uses a patient’s own antigen-presenting cells collected by leukapheresis and exposed ex vivo to a recombinant fusion protein consisting of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). The treated cells are reinfused to stimulate an immune response against PAP-expressing prostate cancer cells.

Administration: Treatment comprises three infusions of the prepared cells, given at approximately two-week intervals, with each infusion typically administered over about 60 minutes.

Clinical evidence: In randomized trials, sipuleucel-T demonstrated a statistically significant improvement in overall survival compared with control therapy. The treatment did not reliably delay disease progression as measured by conventional imaging criteria; thus its benefit is considered survival rather than disease-control. Common adverse events include flu-like symptoms such as chills, fever, fatigue, and myalgia around the time of infusion, as well as potential infusion reactions. Caution is advised in patients with active autoimmune disorders or other immunologic contraindications.

Regulatory and status: Provenge is manufactured by Dendreon and is administered in specialized centers equipped for leukapheresis. Its use is guided by regulatory approvals, clinical guidelines, and payer policies.