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Data updated: Jun 28, 2026

Provenge (sipuleucel-t) · Dendreon Pharmaceuticals LLC

Oncology Approved 2010-04-28

PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
BLA
Biologic
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2010-04-28
Routes
Intravenous
Dosage Forms
Injection

Companies

Dendreon Pharmaceuticals LLC
Active Ingredient: sipuleucel-T

Provenge Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2010 to 2010
Apr 2010 ORIGINAL
Update · CBER biologic (Purple Book)

What Provenge Treats

1 FDA approvals

Originally approved for its first indication in 2010 .

  • Other (1)
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Clinical Trial Registry

23 trials
Trial Sponsor ID Phase Status Title
NCT07219147 25161 NCI-2025-07470, 25161 Ph 1 recruiting 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
NCT05751941 MCC-22003 Ph 2 active not recruiting Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
NCT05806814 OU-SCC-EXCITE OU-SCC-EXCITE Ph 1 active not recruiting Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
NCT06100705 2000035188 Ph 2 recruiting Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
NCT03686683 ProVent results posted P17-1 ProVent Ph 3 completed Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
NCT02159950 results posted I 250813 NCI-2014-01184, I 250813 Ph 2 completed Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT01818986 results posted STU 102012-026 Ph 2 completed Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
NCT02463799 results posted J1522 IRB00056435 Ph 2 completed Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
NCT01706458 results posted CO11816 A534260, SMPH/MEDICINE/MEDICINE*H Ph 2 completed Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
NCT03024216 Rosser-2015-4 Ph 1 completed Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer
NCT01807065 results posted 12367 NCI-2013-00542 Ph 2 completed Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
NCT01560923 results posted 2011LS109 Ph 2 completed Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
NCT02036918 Pro00047231 Ph 1 completed Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer
NCT01487863 results posted P11-3 Ph 2 completed Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
NCT01981122 results posted P12-2 Ph 2 completed A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
NCT02793219 GU-15-103 HSC-MS-15-0882 Ph 2 withdrawn Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer
NCT02793765 GU-15-104 HSC-MS-15-0883 Ph 2 withdrawn Docetaxel Followed by Provenge in Metastatic Prostate Cancer
NCT01832870 SIPIPI 2013 Ph 1 completed Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer
NCT01338012 mCRPC results posted P10-1 Ph 2 terminated Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
NCT01431391 results posted P10-2 Ph 2 completed Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
NCT00715078 results posted P07-2 Ph 2 completed To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
NCT00901342 results posted P09-1 Ph 2 completed Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
NCT01477749 results posted P11-1 2011-001192-39 Ph 2 completed Sipuleucel-T Manufacturing Demonstration Study
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Provenge FDA Label Details

Indications & Usage

PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

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Data Sources

FDA Approval: BLA125197 → Label: DailyMed (2025-10-03) → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.