PROVENGE® (sipuleucel-T) Is FDA Approved

PROVENGE is the first and only FDA approved immunotherapy IMMUNOTHERAPYTreatment that helps the immune system (the body’s natural defense) fight disease.Close for advanced prostate cancer.

PROVENGE is the only personalized treatment that is clinically proven to help extend life in certain men with advanced prostate cancer.

PROVENGE is an immunotherapy IMMUNOTHERAPYTreatment that helps the immune system (the body’s natural defense) fight disease.Closethat takes the patient’s own immune cells and reprograms them to attack his advanced prostate cancer. This process delivers a treatment designed just for each patient.

PROVENGE has proven results as an advanced prostate cancer immunotherapy.

In the clinical trial (IMPACT) that supported FDA approval, more men treated with PROVENGE lived longer than men not treated with PROVENGE.

  • More men in the PROVENGE group were alive 3 years after the start of the study than men not treated with PROVENGE
  • PROVENGE reduced the risk of death by 22.5% for patients in the PROVENGE group
  • Only 1.5% of men discontinued treatment with PROVENGE due to side effects

How It Works

PROVENGE is an immunotherapy IMMUNOTHERAPYTreatment that helps the immune system (the body’s natural defense) fight disease. Close that is designed to reprogram the body’s immune cells to attack advanced prostate cancer cells. By jumpstarting immune cells already in the body, PROVENGE therapy helps take the fight against advanced prostate cancer into the patient’s own hands.

It is important to note that in the PROVENGE clinical trial, the main goal was not to lower PSA levels—it was to extend life. So even if PSA levels do not go down, PROVENGE may help certain men live longer.

PROVENGE Financial Coverage

75% of patients receiving PROVENGE are expected to have minimal to no out-of-pocket costs and PROVENGE is covered by Medicare as well as most other commercial plans.

There are many types of insurance, so be sure to speak with your doctor’s office. You can also get more information about your coverage, as well as whether you are eligible for additional financial support during treatment with PROVENGE, by calling 1-877-336-3736.

Our commitment to patients with limited financial resources

Dendreon wants to make sure help is available for patients who need financial assistance. Patient assistance programs include:

  • PROvide—A new patient assistance program for patients with commercial insurance. PROvide supports eligible patients by covering any combination of cost—co-pays, co-insurance, or deductible costs—to a maximum of $6,000 over the 3 PROVENGE treatments*
  • Co-pay Assistance for Patients With Medicare—Help with co-pays, co-insurance, and deductible costs for eligible patients
  • Support for Patients Without Coverage for PROVENGE—Eligible patients may be able to get PROVENGE free of cost through the PROVENGE Uninsured Patient Program*
  • Travel Cost Assistance—Help with treatment-related travel costs for eligible patients

For more information, please call 1-877-336-3736.

*PROvide, the commercial copay card program, and the Uninsured Patient Program eligibility criteria can be changed or program can be discontinued at any time at the sole discretion of Dendreon, the maker of PROVENGE.

Co-pay and travel assistance foundations provide assistance regardless of the choice of medicine, and decisions are based on financial need and according to criteria established by individual foundations. Dendreon can assist patients by referring them to these independent organizations. Dendreon cannot guarantee that patients will be eligible for or receive assistance after referral. Dendreon does not have controlling or managerial influence on these independent organizations.

To learn more about PROVENGE, visit

Indication and Important Safety Information

PROVENGE® (sipuleucel-T) is approved by the FDA as an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. PROVENGE is made from your own immune cells. Your cells will be collected at a cell collection center approximately 3 days before each scheduled infusion of PROVENGE. There can be risks associated with the cell collection process, which you should discuss with your doctor before deciding to begin treatment with PROVENGE.

PROVENGE can cause serious reactions. In controlled clinical trials for the treatment of prostate cancer, serious reactions reported in patients in the PROVENGE group included reactions resulting from the infusion of the drug, which occurred within 1 day of infusion, and strokes. Severe infusion reactions included chills, fever, fatigue, weakness, breathing problems (shortness of breath, decreased oxygen level, and wheezing), dizziness, headache, high blood pressure, muscle ache, nausea, and vomiting. Tell your doctor right away if you have breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea, or vomiting after getting PROVENGE because any of these may be signs of heart or lung problems.

The most common side effects reported with PROVENGE were chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor.

Tell your doctor about all your medical problems including heart problems, lung problems or a history of stroke.

Tell your doctor right away if you get a fever over 100°F, or redness at the cell collection or infusion sites, because any of these may be signs of infection.

Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements.

Tell your doctor about any side effect that concerns you or does not go away.

For more information on PROVENGE, please see the Full Prescribing Information or call 1-800-667-5924.