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  1. Cellular & Gene Therapy Products

Questions and Answers - Provenge


  1. What is PROVENGE and how does it work?

    PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy designed to stimulate a patient’s own immune system against cancer. PROVENGE is manufactured in several steps. First the patient’s blood is run through a machine in a process known as leukapheresis. During the process, some of the patient’s immune cells are collected. These immune cells are then exposed to a protein intended to stimulate and direct them against prostate cancer. Following this exposure, the activated immune cells are then returned to the patient to treat the prostate cancer.

    PROVENGE is administered intravenously in a three-dose schedule at approximately two week intervals. Each dose is preceded by the leukapheresis procedure approximately three days prior to the scheduled treatment, and is administered only to the patient from whom the cells were obtained.
  2. What are the ingredients in PROVENGE?

    The active components of PROVENGE are autologous antigen presenting cells (APCs) and the protein called PAP-GM-CSF. APCs are activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM‑CSF), an immune cell activator.

    The cellular composition of PROVENGE will vary, depending on the cells obtained from the individual patient during leukapheresis. In addition to the APCs, the product also contains T cells, B cells, natural killer (NK) cells, and other cells.

    Each dose of PROVENGE is suspended in 250 mL of Lactated Ringer’s Injection, USP in a sealed, patient-specific infusion bag.

    PROVENGE contains no preservatives or adjuvants.


  1. What type of cancer will PROVENGE treat?

    PROVENGE is specifically indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The indication for use was approved based on the specific population studied in the clinical trials, which were patients with metastatic castrate resistant (hormone refractory) prostate cancer who had minimal or no symptoms such as pain caused by the prostate cancer.
  1. Can I receive other treatments while being treated with PROVENGE?

    You should carefully discuss all of your treatment options with your doctor before starting any cancer treatment. Your doctor will describe the best course of action for your particular situation.

    The use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given at the same time with the leukapheresis procedure for PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and using immunosuppressive agents at the same time may alter the effectiveness and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE.
  1. Will PROVENGE be limited to a specific age group?

    PROVENGE is not limited to a specific age group. However, prostate cancer is more common in elderly men. In controlled clinical trials, the majority of the men were 65 years of age or older.

    Additional information can be found in the package insert available on our website at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts


  1. Why didn’t FDA approve PROVENGE previously, and why is FDA approving it now?

    The product was discussed at a meeting of FDA’s Cellular, Tissue and Gene Therapies Advisory Committee in March 2007. Following the meeting, and after FDA completed its review of Dendreon’s Biologics License Application (BLA), the agency determined that there were deficiencies in the application that precluded approval and issued a Complete Response (CR) Letter to the firm.

    The deficiencies included the absence of sufficient information to determine that the product would be safe and effective, as well as sufficient information to determine that the facility in which the product is manufactured, processed, packed or held would ensure the continued safety, purity, and potency of the product. Without this information, FDA could not make an approval determination.

    Dendreon Corporation, the manufacturer of PROVENGE, conducted an additional study, and issued a press release describing the results from its pivotal phase 3 study of PROVENGE on April 14, 2009. The firm then filed an amendment to its BLA to include this new data, and FDA has now completed the review of that submission. Based on our review, FDA has determined that the product is safe and effective.


  1. When will PROVENGE be available?

    FDA’s regulatory role is to ensure that products licensed for use in the United States are safe and effective. The determination of when to make a licensed product available is up to the manufacturer, not FDA. We encourage patients to contact the manufacturer, Dendreon, directly for additional information.
  1. How much does PROVENGE cost? Will it be covered by my insurance?

    FDA does not regulate the cost of approved products. We encourage patients to contact the manufacturer concerning questions about cost. Your insurance company will be able to assist you with determining coverage or any other cost issues associated with the administration of PROVENGE.

Alternative Treatments

  1. What are the current treatment alternatives for late-stage prostate cancer patients?

    Metastatic androgen-independent (hormone refractory) prostate cancer is usually incurable. Currently available therapies are intended for palliation and/or prolonging survival. These therapeutic options include additional hormonal manipulations, bisphosphonates to reduce effects of bony metastases, chemotherapy, palliative radiation and pain control. To obtain information pertaining to drug and radiation therapies used to treat prostate cancer, we encourage you to contact your oncologist to discuss all of your treatment options. The National Cancer Institute also has additional information on cancer treatments on its website.


  1. What adverse reactions were reported during the clinical studies of PROVENGE?

    Common adverse reactions reported during a safety evaluation of 601 patients who received PROVENGE were chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions that were reported in patients receiving PROVENGE included some acute infusion reactions and stroke.

    Additional information can be found in the package insert available on our website at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/
  2. How will adverse events associated with PROVENGE be monitored?

    FDA receives spontaneous reports of suspected adverse events from manufacturers, user facilities, healthcare professionals, and consumers through a program called "MEDWATCH, the FDA Medical Products Safety and Adverse Event Reporting Program." Manufacturers are required to report adverse events to FDA. In addition, healthcare professionals and consumers are encouraged to report serious adverse events and product problems to FDA, the manufacturer, or both.

    Adverse event reports come into FDA in many ways--either through MEDWATCH, directly to the Center, or through an FDA District or Field Office. Regardless of the path into the Agency, reports are directed to the appropriate Center to be recorded and reviewed. Healthcare providers and consumers who wish to submit an adverse event report may contact MedWatch at 1-800-332-1088 or via the web.


  1. How was the efficacy of PROVENGE established?

    The effectiveness of PROVENGE was studied in 512 patients with metastatic castrate resistant (hormone refractory) prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial. The study showed an increase in overall survival of approximately 4 months for patients receiving PROVENGE treatments as compared to the control group.

    Additional information can be found in the package insert available on our website at: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/
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