PROVENGE FDA Approval

The U.S. Food and Drug Administration (FDA) granted approval for PROVENGE (sipuleucel-T) in April 2010. However, the FDA had denied this approval back in 2007 because it was not clear whether this medicine was safe and effective for treating prostate cancer. After the manufacturer of the drug completed an additional clinical study, the approval was granted.

When Did the FDA Approve PROVENGE?

PROVENGE® (sipuleucel-T) is a prescription prostate cancer treatment. It was approved by the United States Food and Drug Administration (FDA) in April 2010. With this approval, PROVENGE become the first autologous cellular immunotherapy. This means it uses the body's own cells to stimulate an immune response against prostate cancer.
 
PROVENGE is approved for the treatment of prostate cancer that has spread to other areas of the body (metastatic prostate cancer) and is not responding to standard hormone treatment. It is only approved for use in men who have minimal or no cancer symptoms.
 

Why Did the FDA Approve PROVENGE?

In 2007, the FDA decided not to approve PROVENGE after reviewing information about the medication. PROVENGE was not approved at that time because, in part, there was not enough information available to determine whether the medicine was safe and effective. The FDA sent a letter to Dendreon (the manufacturer of PROVENGE) outlining their findings.
 
After the initial FDA review, Dendreon completed an additional PROVENGE clinical study. In this study, men given PROVENGE survived approximately four months longer than men who received a placebo (a medication that does not contain any active ingredients). Based on the results from this additional study, the FDA was able to determine that PROVENGE is safe and effective for the treatment of metastatic prostate cancer.
 
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Written by/reviewed by: Susan Lakey, PharmD, MPH
Last reviewed by: Kristi Monson, PharmD
 
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