PROVENGE FAQs and Quick Facts

Below are some of the most common questions about PROVENGE. Click on a topic to learn more:

About PROVENGE

What is PROVENGE?

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). It is the first and only FDA-approved immunotherapy for prostate cancer.

PROVENGE is made by culturing a patient's own immune cells with a recombinant antigen* that is prostate-specific. When infused into the patient, PROVENGE activates T cells to target and attack prostate cancer cells.

*The recombinant antigen is called PAP-GM-CSF. It is comprised of prostatic acid phosphatase (PAP), an antigen expressed in more than 95% of prostate cancers, and granulocyte macrophage colony stimulating factor (GM-CSF), an immune cell activator.

Learn more about PROVENGE

What are the NCCN recommendations for PROVENGE?

NCCN Category 1 Recommendation
The National Comprehensive Cancer Network (NCCN) recommends PROVENGE as first-line treatment for men with asymptomatic or minimally symptomatic castrate-resistant prostate cancer (mCRPC).1

  1. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. V.3.2012. National Comprehensive Cancer Network Web site. www.nccn.org

When was PROVENGE FDA-approved?

On April 29, 2010, the US FDA approved PROVENGE, an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

"The approval of PROVENGE, the first autologous cellular immunotherapy, represents a significant scientific and clinical advancement for the treatment of prostate cancer," said Philip W. Kantoff, MD, Dana-Farber Cancer Institute, Harvard Medical School. "Cancer immunotherapies that use the patient's own immune system will likely create an entirely new treatment paradigm for patients with cancer."

Who manufactures PROVENGE?

PROVENGE is the first oncology therapeutic made by Dendreon Corporation.

Dendreon Corporation (NASDAQ: DNDN) is a biotechnology company focused on the discovery, development, and commercialization of novel therapeutics that may significantly improve cancer treatment options for patients. The company applies its expertise in antigen identification, engineering, and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon is headquartered in Seattle, Washington, and has manufacturing facilities in Georgia and California.

Learn more about Dendreon

What is immunotherapy?

Immunotherapy is a treatment that helps the immune system fight disease. PROVENGE is the first and only FDA-approved, personalized immunotherapy for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC). PROVENGE is made by culturing a patient’s own immune cells with a recombinant antigen that is prostate-specific. When infused into the patient, PROVENGE activates T cells to target and attack prostate cancer.

Learn more about PROVENGE as immunotherapy

What is the PROVENGE Full Prescribing Information?

You can download the PROVENGE Full Prescribing Information here.

Where can I find an overview of PROVENGE for physicians?

On this site, you can find information about PROVENGE efficacy, learn about the PROVENGE difference, and read about safety & side effects of PROVENGE.

Where can I find an overview of PROVENGE for patients?

Share the PROVENGE patient brochure with your patients who are considering treatment with PROVENGE.

What is the efficacy benefit of PROVENGE?

PROVENGE Extends Median Survival Beyond 2 Years

PROVENGE delivers statistically significant survival advantage by extending median overall survival beyond 2 years. Survival advantage was confirmed in two Phase 3 studies.1,2

  1. PROVENGE [package insert]. Dendreon Corporation; June 2011.
  2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

Learn more about extending survival with PROVENGE

What are the risks and side effects of PROVENGE?

Only 1.5% of patients in the pivotal Phase 3 IMPACT Trial discontinued treatment with PROVENGE due to adverse events.

Common Adverse Events

The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache

Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting
  • Most acute infusion reactions (occurring within 1 day of infusion) in the PROVENGE group were transient, resolving within 2 days
  • 95.1% were mild or moderate in severity
PROVENGE does not require dosage adjustments, monitoring of liver/kidney functions, or concomitant steroids

Autologous use

  • PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases
Serious adverse events
  • In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group
Common adverse events

The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Learn more about the demonstrated safety of PROVENGE

What is leukapheresis?

Leukapheresis is a standard cell-collection procedure performed at a blood center. During a leukapheresis procedure, blood is drawn from a machine that removes a small portion of your patient’s immune cells, along with some platelets and a small number of red blood cells. The machine returns the rest of the cells and blood to the body.

Prior to your patient’s first leukapheresis procedure, venous assessment must be done by the prescribing practitioner to determine if the patient’s veins can accommodate the leukapheresis procedure. If they cannot, placement of a central venous catheter is necessary. In the Phase 3 IMPACT Trial, 23% of patients received central venous catheters.

Following leukapheresis, your patient’s immune cells will be picked up and sent to a Dendreon manufacturing facility to be made into a dose of PROVENGE specifically for your patient.

Learn how to properly administer PROVENGE

Reimbursement/Support Services

What is the reimbursement coverage for PROVENGE?

PROVENGE reimbursement is comprehensive:

  • Medicare—All Medicare Administrative Contractor regions cover PROVENGE for use within the FDA-approved label per the National Coverage Determination
  • Commercial—Health care plans representing approximately 99% of patients with private insurance cover PROVENGE for use within the FDA-approved label

In addition, Dendreon provides a variety of support services to help facilitate treatment with PROVENGE. These services focus on patient assistance programs, supporting the reimbursement process, and product ordering support.

Dendreon ON Call is designed to be a comprehensive and convenient resource for health care professionals seeking to use PROVENGE for their patients. When a patient begins therapy with PROVENGE, dedicated Dendreon ON Call reimbursement coordinators will provide support with the reimbursement process, and local field reimbursement business managers will be available to answer questions upon request.

Examples of assistance that a reimbursement coordinator can provide include:

  • Patient enrollment, to ensure accuracy and minimize delays
  • Benefits verification
  • Prior authorization criteria support
  • Claims appeal support

Learn more about PROVENGE reimbursement resources here

or call Dendreon ON Call at 1-877-366-3736.

Is there support for patients receiving PROVENGE?

75% of patients receiving PROVENGE are expected to have minimal to $0 out-of-pocket costs. But for those with no coverage for PROVENGE, or who need help covering costs, Dendreon supports several patient assistance options, including:

  • Assistance with co-pay, co-insurance, and deductible costs for Medicare patients
  • Assistance with treatment-related travel costs for Medicare and commercially insured patients*

In addition, Dendreon sponsors two additional programs that provide assistance for PROVENGE:

  • PROvide, for patients covered through commercial insurance
  • PROVENGE Uninsured Patient Program, for patients without coverage for PROVENGE or who are rendered uninsured as a result of a final payer claim denial

*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 ON Call 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.

PROvide, the commercial co-pay 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.

Learn more about Dendreon Patient Assistance programs

How do I become a PROVENGE Treatment Center?

Help your patients sustain* their fight against advanced prostate cancer by providing PROVENGE.

Call Dendreon ON Call at 1-877-336-3736 to register today.

When you become a PROVENGE Treatment Center, Dendreon, the makers of PROVENGE, will provide your practice and your patients with:

  • Comprehensive support services throughout the course of therapy
  • Help simplifying the insurance process
  • Assistance in scheduling procedures
  • Detailed training and ongoing product support

*A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1

Visit Dendreon ON Call online to learn more.

  1. PROVENGE [package insert]. Dendreon Corporation; June 2011.
For Your Patients

Which patients may be appropriate for PROVENGE?

PROVENGE is indicated for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC).

Consider PROVENGE for patients:
  • With metastatic castrate-resistant prostate cancer (CRPC)
  • Who are asymptomatic or minimally symptomatic
  • Who do not require narcotic analgesics for cancer-related pain

PROVENGE does not preclude the use of subsequent therapies.

Learn more about identifying PROVENGE patients

Does PROVENGE affect my patient’s PSA?

PSA Levels and PROVENGE

Changes in PSA levels may not reflect treatment response to PROVENGE.1

Cytotoxic therapies have their greatest effects soon after initiation of therapy, while immunotherapies such as PROVENGE require time to generate an immune response, and evidence of activity may be delayed.2,3

  1. Data on file.
  2. Madan RA et al. Oncologist. 2010;15:969-975.
  3. Food and Drug Administration, Guidance for industry: clinical considerations for therapeutic cancer vaccines. Center for Biologics Evaluation and Research, Food and Drug Administration, US Dept of Health and Human Services. September 2009;1-13.

Learn more about how PROVENGE is different

How long is a course of PROVENGE therapy?

PROVENGE therapy can be completed in about one month, and a sustained immune response to PROVENGE was seen out to 26 weeks in the pivotal study (the last time point measured).

PROVENGE therapy is administered in three 1-hour infusions, each preceded by a standard leukapheresis procedure (a standard cell-collection procedure performed at a blood center).

  • The dosing interval ranged from 1 to 15 weeks in controlled clinical trials1
  • Leukapheresis and PROVENGE infusions are scheduled 2 to 3 days apart and can start on various days of the week
  1. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

Learn more about the PROVENGE therapy duration

What information do my patients need to know about PROVENGE?

PROVENGE is a treatment option for certain men with advanced prostate cancer. PROVENGE is the first and only FDA-approved treatment that uses the body's own immune system to fight prostate cancer.

PROVENGE is not a chemotherapy, or hormone therapy. PROVENGE is an immunotherapy that works by stimulating the natural ability of immune cells already in the blood to attack prostate cancer cells, which may help your patients live longer.

You may consider reviewing this information with your patients in your office.