UPDATE 2-US FDA objects to Dendreon promotions for Provenge

Fri Aug 6, 2010 5:34pm EDT

* FDA letter: Company overstated benefits, minimized risks

* Dendreon shares end higher (Adds company comment, details on product; updates shares)

WASHINGTON Aug 6 (Reuters) - Dendreon Corp (DNDN.O) exaggerated the benefits of its novel prostate cancer vaccine and downplayed risks in some sales materials for the product, U.S. regulators said in a letter released on Friday.

"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the U.S. Food and Drug Administration said in a letter to the company.

Some of Dendreon's promotions included a chart that "does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of" the company's main study, the FDA said.

The materials also left out some information about sterility testing, the agency said.

The FDA asked Dendreon to immediately stop using the promotions and any others with similar claims.

Dendreon spokeswoman Katherine Stueland said the company "has spoken with the FDA and intends to comply with the request."

The FDA approved Provenge in April for treating advanced prostate cancer.

Unlike traditional vaccines that prevent a disease, Provenge treats prostate cancer by stimulating the body's own immune system to attack malignant cells. It is produced by taking cells from a patient's tumor and incorporating them into a vaccine that is injected back into the patient.

Dendreon shares fell slightly after the FDA letter was released but recovered to close 1.5 percent higher at $39.05 on Nasdaq.

The FDA posted the letter here. (Reporting by Lisa Richwine. Editing by Robert MacMillan, Bernard Orr)

Related Quotes and News

Company
Price
Related News
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
Comments (1)
STOPCHEATING wrote:
“stimulating the body’s own immune system to attack malignant cells”???? where is the evidence that the product attacking tumor cells? Zero!!!! to be honest. How could there be a difference in survival? suppressing the control!!! Most likely, patients sacrify eventually. This is not whether people are anti-P, but rather what is right for patients. A difference in survival is not same as an improvement in suvuval!

Aug 06, 2010 11:23pm EDT  --  Report as abuse
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.