Provenge has finally received the long awaited approval from the FDA!!! We all celebrate and look forward to benefiting from its potential to extend our life.

Provenge is the first immunologic therapy ever approved in the United States to treat cancer. (In Russia, Antigenics has received approval for an immunological treatment for kidney cancer).

The FDA’s approval of Provenge is very narrow, just for men who have castrate resistant metastatic, asymptomatic prostate cancer. This means that you must have prostate cancer tumors outside of the gland, not have any symptoms and you are no longer responding to hormone therapy.

Despite this limited approval, I believe that the first year’s demand for the treatment will out strip the ability of Dendreon (the bio-tech company that developed Provenge) to accommodate all the men who wish to get the treatment (Dendreon has indicated they believe they will only be able to treat 2,000 this, their initial year). Although there will be doctors attempting to write “off label” prescriptions for the treatment, I do not expect that many men, if any, will be successful in obtaining the treatment if they are outside the very strict approval parameters.

Dendreon has been aware of the potential initial supply problems they will face in meeting the very early demand. The company is very sensitive to this issue and has taken the lead in trying to find ways to mitigate the problem. Despite the fact that they had not received FDA approval, they are well into a large building program that includes expanding their physical plant in three separate locations in the United States as well as hiring and training a large cadre of workers to so they will be able to hit the ground running. I applaud Dendreon for their willingness to “stick their necks out,” even before the FDA approval.

Hopefully, within the first year, they will be able to catch up to the demand along with continuing additional trials to demonstrate that Provenge in earlier disease can also offer survival extension.

Initially, Provenge’s availability will be limited solely to the United States. The FDA approval will not effect approval in any other country. Provenge is custom made for each man by a process that modifies a man’s own personal blood product. The modification process and reintroduction of the processed blood must be completed in a matter of a few days, so Dendreon has set up a network of 50 infusions sites (this number will be expanded in the future) throughout the United States so any man in the States will be able to access the treatment.

HOW DO I GET PROVENGE?

This is the million dollar question we all want to know, here is the answer.

First you need to make sure that you qualify under the approval status. This means that you must:

1- Have metastatic disease.
2- Be castrate resistant (failed ADT).
3- Be asymptomatic (not have any or minimal symptoms).

If you meet these criteria your next step is to contact the call center at: 877-336-3736. The call center will review your status to confirm that you believe you meet the above requirements. If you do, they will provide contact information, including locations of the infusion centers near you.

You should then contact the infusion center near you. The intake individual will again review and confirm that you meet the above criteria. They will probably ask for your medical records and might also want to speak with your treating physician to confirm the information.

Once these items have been resolved, they will schedule you for an appointment where your medical status will again be reviewed and you may possibly be examined by the on-site physician. The staff at the infusion site will review with you the treatment protocol. The infusion site will also confirm your insurance status and if needed receive approval for the treatment.

Once approved you will be schedule with your first appointment to begin the actual treatment protocol.

Dendreon will be setting up a patient assistance program to help provide economic assistance to anyone unable to afford their insurance co-payment. You can contact their call center (877-336-3736) to learn how to access this program

We hope to see some clinical trials of Provenge in the near future for men with hormone dependent disease, but I am not optimistic that these trials will begin for another two to three years, at the earliest. Then, the trials will need to be continued for many additional years to allow survival data to be collected.

I am a strong believer in the potential of immunological treatments for prostate cancer as well as other cancers. I believe that they will provide an important future treatment alternative which when coupled with other treatments will extend our life with a minimal degradation of the quality of life.

For the more technical individuals the following has been released by Dendreon:

PROVENGE® Fact Sheet
PROVENGE® (sipuleucel-T) is the first FDA-approved autologous cellular immunotherapy indicated for the treatment of men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormonerefractory) prostate cancer. PROVENGE is designed to stimulate an immune response against prostate cancer.

FDA Approval; Pivotal Clinical Trial Data

PROVENGE was granted licensure by the U.S. Food and Drug Administration (FDA) on April 29, 2010, 2010. The pivotal clinical trial on which the FDA approval of PROVENGE was based was D9902B, also known as IMPACT (Immunotherapy for Prostate AdenoCarcinoma Treatment).

The IMPACT Trial:

Phase 3, randomized, double-blind, placebo-controlled trial, which enrolled 512 men with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (CRPC)

The primary endpoint was overall survival

The trial met its primary endpoint of significantly improving overall survival in the PROVENGE group compared with the control group.

Median survival for patients in the PROVENGE group was 25.8 months compared with
21.7 months for patients in the control group (P=.032)

PROVENGE reduced the risk of death by 22.5% compared with those in the control group
(HR=0.775,95% CI: 0.614, 0.979)

Important Safety Information

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

Serious adverse reactions reported in the PROVENGE group were acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions occurred 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.

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

PROVENGE Administration

A complete course of PROVENGE is 3 infusions, typically administered approximately 2 weeks apart. The dosing interval ranged from 1 to 15 weeks in controlled clinical trials.

Frequently Asked Questions

How does PROVENGE work?

PROVENGE (PROH-venj) is designed to stimulate a patient’s immune system to target prostate cancer cells. The process of making PROVENGE involves the introduction of a patient’s immune cells to a protein that functions as a prostate-cancer associated antigen. An antigen is a substance that causes the body to react with an immune response. This process activates the patient’s immune cells against prostate cancer cells to help the immune system better fight the disease.

How common is prostate cancer?

According to the American Cancer Society’s 2009 statistics, prostate cancer is the most common non-skin cancer in men in the United States and the third most common cancer worldwide. More than two million men in the United States have been diagnosed with prostate cancer. In 2009, an estimated 192,280 new cases were expected to be diagnosed, and approximately 27,360 men were expected to die from the disease.

Are there PROVENGE studies currently enrolling?

Yes. NeoACT (NEOadjuvant Active Cellular immunoTherapy) is a Phase 2 single-site trial in men with localized prostate cancer who are scheduled to undergo a prostatectomy.

ProACT (PROstate cancer Active Cellular immunoTherapy) is a Phase 2 multicenter trial in men with asymptomatic or minimally symptomatic, metastatic CRPC. The target enrollment is 120 patients.

For more information on the current status of PROVENGE clinical trials, please visit www.clinicaltrials.gov.

Where is PROVENGE available?

At launch, treatment will be available through approximately 50 centers across the country, previously approved as clinical trial sites. When our manufacturing capacity increases, PROVENGE will become more broadly available. Dendreon is in the process of expanding its New Jersey facility in the first half of 2011 and the construction of facilities in Atlanta, Georgia and Orange County, California, is expected to be complete in mid-2011.

How can I get PROVENGE?
Dendreon is committed to helping patients gain access to PROVENGE. Dendreon ON Call is available to answer questions about PROVENGE treatment, coverage and reimbursement, and patient support.

For more information, healthcare providers and patients may contact Dendreon ON Call at 1.877.336.3736, Monday through Friday from 8 a.m. to 11 p.m. ET.

For more information, visit www.PROVENGE.com or contact Dendreon ON Call1-877-336-3736

1 American Cancer Society, Detailed Guide to Prostate Cancer: What are the key statistics about prostate cancer?
P-A-04.10-010.00

Joel T Nowak, MA, MSW