News Summary

• The University of Minnesota is the first site in Minnesota and one of the first sites in the United States to offer the newly FDA approved drug PROVENGE®  to treat men with advanced metastatic prostate cancer.
• PROVENGE is the first FDA-approved autologous cellular immunotherapy, meaning the treatment is made from the patient’s own cells and works to boost the patient’s immune system to fight the prostate cancer.
• This new type of treatment option is not a cure, but improves the length of time some patients may live. Additionally, as the first autologous cellular immunotherapy to receive FDA-approval, it opens the door for research development of other immunotherapies for treatment of other cancers.

Quotes

“PROVENGE is not for every patient with prostate cancer and it is not a cure, but it is a breakthrough treatment that can possibly mean longer life for some patients for whom the clock is ticking down,” said Robert Kratzke, M.D., a medical oncology physician-researcher with the University of Minnesota Medical School and Masonic Cancer Center.

“This finding sets the stage for further research on the use of PROVENGE in patients with less advanced prostate cancer and for development of other immunotherapies that may create a whole new treatment approach for patients with various stages of prostate cancer,” said Badrinath Konety, M.D., University of Minnesota’s chief of urology and director of the Center for Prostate Cancer.

Full Text

MINNEAPOLIS / ST. PAUL (October 4, 2010) – The University of Minnesota is the first site in Minnesota and one of the first sites in the United States to offer the recently U.S. Food and Drug Administration (FDA) approved drug PROVENGE® (sipuleucel-T) to treat men with advanced metastatic prostate cancer.

PROVENGE (pronounced Pro-venge) is the first FDA-approved autologous cellular immunotherapy, meaning the treatment is made from the patient’s own cells and works to boost the patient’s immune system to fight the prostate cancer.

Made by Dendreon, this new type of treatment option is not a cure, but improves the length of time some patients may live. Additionally, as the first autologous cellular immunotherapy to receive FDA-approval, it opens the door for research development of other immunotherapies for treatment of other cancers.

Thus far, 38 patients with advanced metastatic prostate cancer have been scheduled to receive PROVENGE at the University’s Masonic Cancer Clinic. Because of manufacturing constraints, the current availability of PROVENGE is limited. Dendreon is in the process of expanding manufacturing facilities to increase capacity to make the drug.

“PROVENGE is not for every patient with prostate cancer and it is not a cure, but it is a breakthrough treatment that can possibly mean longer life for some patients for whom the clock is ticking down,” said Robert Kratzke, M.D., a medical oncology physician-researcher with the University of Minnesota Medical School and Masonic Cancer Center.

Kratzke led the phase 3 clinical trial on PROVENGE at the University and is now overseeing the treatment program. He also contributed to a scientific article about the treatment that was published in the New England Journal of Medicine (July 2010).

PROVENGE validates an immunotherapy approach for treatment of prostate cancer, which previously was thought to be immune resistant, said Badrinath Konety, M.D., University of Minnesota’s chief of urology and director of the Center for Prostate Cancer.

“PROVENGE is the first autologous cellular immunotherapy to meet the gold standard of cancer treatment in that it was tested in a national phase 3 randomized clinical trial involving 512 patients with advanced metastatic prostate cancer and found to improve survival,” Konety said. “This finding sets the stage for further research on the use of PROVENGE in patients with less advanced prostate cancer and for development of other immunotherapies that may create a whole new treatment approach for patients with various stages of prostate cancer.”

About the drug

Who is PROVENGE for?
Patients diagnosed with metastatic, castrate-resistant (hormone-refractory) prostate cancer may qualify for this treatment.

How does PROVENGE work?
PROVENGE is a time-sensitive treatment that must be produced and given within a specific schedule. The process begins with the patient’s own cells being collected through a blood drawing process called leukapheresis and shipped to a Dendreon production facility. There the cells are processed with a recombinant protein, which helps to activate the patient’s immune system and functions as a prostate cancer associated antigen. This allows the patient’s immune system to recognize and attack the prostate cells.

PROVENGE is then shipped back within a few days and infused into the patient. The treatment involves three doses given about two weeks apart. The entire process takes one month. If the schedule cannot be kept, the process must start all over again.

What are the side effects?
The reported side effects are typically mild flu-like symptoms of chills, fever, and headache for a day or two after receiving the treatment.

What is the survival time?
PROVENGE was found to improve survival an average of 4.1 months over placebo in the IMPACT clinical trial findings that led to the FDA approval. By comparison, in 2006 the FDA approved the drug Taxotere for prostate cancer treatment on a median survival benefit of 2.5 months.

What is the availability of PROVENGE?
PROVENGE is initially being made available at 50 cancer centers in the United States. These are sites that participated in the clinical trials conducted to test the treatment. Dendreon’s anticipates being at full production capacity by mid-2011.

What is the cost of treatment?
The cost for the drug is about $93,000 and may not always be covered by Medicare or other insurance. The hospital reimbursement depends on insurance contracts and is different for each insurer, and may even differ from one patient to next who have different policies within the same insurer.

Where can I get more information?
For more information about PROVENGE and its availability, either call toll-free 1-877-336-3736 (1-877-DENDREON) or visit www.PROVENGE.com.