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Dendreon Announces MEDCAC Panel Reviewed PROVENGE Evidence
Date:11/17/2010

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence greater than or equal to 15%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported 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.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full Prescribing Information at www.provenge.com or call Dendreon ON Call at 1-877-336-3736

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of
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SOURCE Dendreon Corporation
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Related biology technology :

1. Dendreon Submits Post-Approval Supplement to the PROVENGE Biologics License Application for New Jersey Manufacturing Facility
2. Dendreon to Host Conference Call on November 3rd to Announce Third Quarter Financial Results
3. Dendreon Announces Change in Board of Directors
4. Dendreon Announces Election of Dr. David C. Stump to Board of Directors
5. Dendreon Announces Presentation of PROVENGE Data at the American Society of Clinical Oncology Annual Meeting
6. Dendreon Announces Exercise of Option by Underwriters in its Common Stock Offering
7. Dendreon Announces Pricing of Common Stock Offering
8. Dendreon Appoints Hans Bishop as Chief Operating Officer
9. Dendreon Announces Proposed Public Offering of Common Stock
10. Dendreon Receives FDA Acknowledgement of Complete Response
11. Dendreon Reports Third Quarter 2009 Financial Results and Continuing Progress Toward PROVENGE Commercialization
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