Thursday, April 29, 2010

FDA Approves Provenge for Men With Advanced Prostate Cancer

This information is directly from the Dendreon Website (The manufacturer of Provenge)
PROVENGE® (sipuleucel-T) Is Now FDA Approved
PROVENGE is an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is made using cells from a patient's own immune system, so it cannot be warehoused like many other drugs and requires specialized manufacturing facilities.

Within the first year of FDA approval, Dendreon anticipates being able to manufacture PROVENGE to support the treatment of about 2,000 patients. At launch, treatment will be available through approximately 50 centers across the country previously approved as clinical trial sites. As our manufacturing capacity increases over the next 12 months, PROVENGE will become more broadly available.

How It Works

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.

Additional information is provided in the FDA news release located on PR Newswire.

This is very exciting news for the cancer community because it is the first cancer immunotherapy product sometimes called an "individualized cancer vaccine" to receive FDA approval.

We have highlighed Dendreon on our Lots To Live For, Inc. Resources Page for many years.

Here is a NY Times article about the Provenge approval.
F.D.A. Approves Vaccine for Prostate Cancer
Published: April 29, 2010
The treatment is the first to use a so-called cancer vaccine that trains the body’s immune system to fight the disease.