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Provenge FDA 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 timeline for Provenge

Apr 29, 2010Approval FDA Approves Provenge - a Cellular Immunotherapy for Men With Advanced Prostate Cancer
Nov 22, 2009Dendreon Receives FDA Acknowledgement of Complete Response for Provenge
Nov  2, 2009Dendreon Completes Submission of Biologics License Application for Provenge
Jul 30, 2007D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame
Jun  1, 2007Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge
May 31, 2007Dendreon Announces FDA Confirms Data Required for Provenge Licensure
May  9, 2007Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application
Mar 30, 2007Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer
Mar 27, 2007Dendreon to Hold Post Advisory Committee Conference Call for Provenge
Mar  1, 2007Dendreon 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, 2007Dendreon’s Provenge Granted FDA Priority Review
Nov 13, 2006Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer
Aug 24, 2006Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for Provenge
Sep 14, 2005Dendreon Announces Plans to Submit BLA

Further information

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