Provenge Approval History
FDA Approved: Yes (First approved April 29, 2010)
Brand name: Provenge
Generic name: sipuleucel-T
Dosage form: Suspension for Intravenous Infusion
Previous Name: APC8015
Company: Dendreon Corporation
Treatment for: Prostate Cancer
Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
Development History and FDA Approval Process for Provenge
| Date | Article |
|---|
| Apr 29, 2010 |  FDA Approves Provenge - a Cellular Immunotherapy for Men With Advanced Prostate Cancer |
| Nov 22, 2009 | Dendreon Receives FDA Acknowledgement of Complete Response for Provenge |
| Nov 2, 2009 | Dendreon Completes Submission of Biologics License Application for Provenge |
| Jul 30, 2007 | D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not
FDA To Blame |
| Jun 1, 2007 | Prostate Cancer Patients, Survivors and Advocates Assemble on
Capitol Hill to Rally against FDA's Non Approval of Provenge |
| May 31, 2007 | Dendreon Announces FDA Confirms Data Required for Provenge
Licensure |
| May 9, 2007 | Dendreon Receives Complete Response Letter From FDA for Provenge
Biologics License Application |
| Mar 30, 2007 | Dendreon Announces FDA Advisory Committee Reviewed Provenge for
Hormone Refractory Prostate Cancer |
| Mar 27, 2007 | Dendreon to Hold Post Advisory Committee Conference Call for Provenge |
| Mar 1, 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 |
| Jan 16, 2007 | Dendreon’s Provenge Granted FDA Priority Review |
| Nov 13, 2006 | Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer |
| Aug 24, 2006 | Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge |
| Sep 14, 2005 | Dendreon Announces Plans to Submit BLA |
Further information
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