Provenge
Generic name: sipuleucel-T
Treatment for: Prostate Cancer
Dendreon’s Provenge Granted FDA Priority Review
FDA Accepts Provenge Biologics License Application
SEATTLE, January 16, 2007 -- Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and has assigned priority review status to the Company's Biologics License Application (BLA) for Provenge (sipuleucel-T), its investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
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. The goal for reviewing a product with Priority Review status is six months from the filing date. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the Provenge BLA is May 15, 2007.
"Clinical trials have shown that Provenge increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options," said Mitchell H. Gold, president and chief executive officer of Dendreon. "We are extremely pleased the FDA has granted priority review to Provenge, which may represent an important new treatment option for men suffering from prostate cancer."
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 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 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 of which were published in the July issue of the Journal of Clinical Oncology.
About Provenge
Provenge (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) 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: January 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 Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer - March 1, 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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