PROVENGE® (sipuleucel-T) Resources

Founded on the belief that immunotherapy made from a patient’s own cells will transform cancer treatment, Dendreon is fighting for patients by making the battle against cancer personal. By harnessing the power of the body’s immune system, we help extend the lives of men battling cancer.

Our flagship product, PROVENGE, was the first FDA-approved immunotherapy made from a patient’s own immune cells. Today, we continue to push our research forward so that we may help even more men fight cancer with personalized immunotherapy.

Our History

Dendreon pioneered immunotherapy in the fight against advanced prostate cancer. See below for a timeline of this breakthrough innovation.

  • Inspired by their research at Stanford School of Medicine, Edgar Engleman and Samuel Strober establish Activated Cell Therapy
  • Activated Cell Therapy opens its first R&D facility
  • The Antigen Delivery CassetteTM is developed, which will become the basis of the Active Cellular Immunotherapy platform
  • Activated Cell Therapy changes its name to Dendreon
  • Dendreon moves its headquarters to Seattle, Washington
  • Dendreon enters the NASDAQ with an IPO of $45 million to fund trials and preclinical activities for therapeutic cancer vaccines
  • Dendreon is awarded a US patent (No.6,210,662) for the composition of sipuleucel-T
  • Phase 3 IMPACT study evaluating sipuleucel-T in men with advanced prostate cancer begins.
  • Study results eventually serve as the basis for US Food and Drug Administration (FDA) approval
  • Dendreon completes Biologics License Application (BLA) submission to the FDA – the first BLA for an active cellular immunotherapy for cancer
  • The FDA´s Advisory Committee votes in favor of the safety and efficacy of PROVENGE, advancing sipuleucel-T toward FDA approval
  • Patients and advocates rally for PROVENGE after the FDA requests additional efficacy data
  • Dendreon completes Phase 3 IMPACT clinical trial and reports positive topline results
  • Dendreon receives FDA approval for sipuleucel-T (PROVENGE), the first FDA-approved immunotherapy made from a patient´s own immune cells
  • Commercial manufacturing of PROVENGE begins in Morris Plains, New Jersey
  • The New England Journal of Medicine publishes results of the IMPACT trial demonstrating that PROVENGE extends median overall survival for men with advance prostate cancer by 4.1 months
  • The FDA approves PROVENGE manufacturing sites in Seal Beach, California, and Union City, Georgia
  • More than 10,000 men have been prescribed PROVENGE
  • The National Comprehensive Cancer Network (NCCN) recommended PROVENGE for first-line use in patients with M1 CRPC
  • Valeant Pharmaceutical acquires Dendreon
  • More than 20,000 men are prescribed PROVENGE
  • Dendreon resumes operations as a standalone company following acquisition by Sanpower Group
  • Over 30,000 men have been prescribed PROVENGE
  • Dendreon celebrates the 10th anniversary of the FDA´s approval of PROVENGE
  • Over 40,000 men have been prescribed PROVENGE

PROVENGE immunotherapy works differently.
Learn more about the science behind PROVENGE.


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PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.


Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Full Prescribing Information.