Sipuleucel-T

Overview

Sipuleucel-T is a personalized, autologous, cellular immunotherapy. Sipuleucel-T is a therapeutic cancer vaccine for prostate cancer. Sipuleucel-T selectively targets the prostate-specific antigen (PSA) known as prostatic acid phosphatase (PAP) that is expressed in around 95% of prostate cancers. It must be prepared specifically for each patient. In metastatic prostate cancer, it has extended survival by median 4.1 months (IMPACT Phase III trial data). Sipuleucel-T is marketed under the brand name Provenge by Dendreon Corporation. Sipuleucel-T was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic Hormone-Refractory Prostate Cancer (HRPC). The treatment initially cost $93,000 at the time of FDA approval, but rose to over $100,000 in 2014.

Indication

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

Associated Conditions

Asymptomatic, metastatic hormone-refractory Prostate cancer
Minimally symptomatic, metastatic hormone-refractory Prostate cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T	2023/11/18	NCT06134232	Not Applicable	Recruiting	Dendreon
Sipuleucel-T Combined with Bipolar Androgen Therapy in Men with MCRPC	2023/10/25	NCT06100705	Phase 2	Recruiting	Yale University
Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer	2023/04/10	NCT05806814	Phase 1	Recruiting	University of Oklahoma
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer	2023/03/02	NCT05751941	Phase 2	Recruiting	H. Lee Moffitt Cancer Center and Research Institute
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer	2018/09/27	NCT03686683	Phase 3	Completed	Dendreon
Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer	2017/01/18	NCT03024216	Phase 1	Completed	University of Hawaii
Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing	2015/02/03	NCT02353715	N/A	Completed	Duke University
A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T	2014/09/05	NCT02232230	N/A	Completed	GenesisCare USA
Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer	2014/01/15	NCT02036918	Phase 1	Completed	Duke University
Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer	2013/04/16	NCT01832870	Phase 1	Completed	Prostate Oncology Specialists, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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