Provenge
Generic name: sipuleucel-T
Treatment for: Prostate Cancer
Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
SEATTLE, March 1, 2007 -- Dendreon Corporation today announced that the U.S. Food and Drug Administration's Office of Cellular, Tissue and Gene Therapies Advisory Committee will review the Biologics License Application (BLA) for Provenge (sipuleucel-T), the Company's investigational active cellular immunotherapy (ACI) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer on March 29, 2007. The Center for Biologics Evaluation and Research (CBER) has oversight of the Cellular, Tissue and Gene Therapy Advisory Committee.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases of prostate cancer diagnosed each year. More than 27,000 men die each year of the disease.
The BLA submission is based primarily on an improvement in overall survival observed in Study D9901, a multi-center, randomized, double-blind, placebo-controlled Phase 3 Study. The results from D9901 were published in the July issue of the Journal of Clinical Oncology.
Dendreon completed the submission of its BLA for Provenge in November 2006, and the FDA accepted the filing and assigned Priority Review status for the application in January 2007. Priority Review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Based on the FDA's designation of Priority Review for Provenge, the Company anticipates action by the FDA approximately six months from the submission date, or by May 15, 2007.
About Provenge
Provenge is an investigational product that may represent the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system. Provenge is in late-stage clinical development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
Source: Dendreon Corporation
Posted: March 2007
Related articles
- FDA Approves Provenge - a Cellular Immunotherapy for Men With Advanced Prostate Cancer - April 29, 2010
- Dendreon Receives FDA Acknowledgement of Complete Response for Provenge - November 22, 2009
- Dendreon Completes Submission of Biologics License Application for Provenge - November 2, 2009
- D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame - July 30, 2007
- Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge - June 1, 2007
- Dendreon Announces FDA Confirms Data Required for Provenge Licensure - May 31, 2007
- Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application - May 9, 2007
- Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer - March 30, 2007
- Dendreon to Hold Post Advisory Committee Conference Call for Provenge - March 27, 2007
- Dendreon’s Provenge Granted FDA Priority Review - January 16, 2007
- Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer - November 13, 2006
- Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge - August 24, 2006
- Dendreon Announces Plans to Submit BLA - September 14, 2005
Provenge (sipuleucel-T) FDA Approval History
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