Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author)

FDA Identifies No New Safety Concerns Associated with Prostate Cancer Treatment Vaccine Sipuleucel-T

MedicalResearch.com Interview with:

Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author)

Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author)

Dr. Graca Dores MD MPH
US Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Biostatistics and Epidemiology
Division of Epidemiology
Silver Spring, Maryland
Oklahoma City, OK

MedicalResearch.com: What is the background for this study? Would you briefly explain what Sipuleucel-T is used for? 

Response: Sipuleucel-T was the first therapeutic vaccine approved by the U.S. Food and Drug Administration (FDA) in 2010.  It is indicated for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (CRPC; prostate cancer that spreads while an individual is on hormone-blocking therapy).  During the preparation of this product, the patient’s cells are collected (leukapheresis), sent for processing to generate a dose of patient-specific vaccine, and then administered intravenously back to the patient.  This process is repeated approximately every two weeks for a total of three doses.

Except for the pre-marketing clinical trials that were reviewed during the sipuleucel-T approval process, post-marketing studies that have evaluated the safety profile of sipuleucel-T are scarce. Therefore, we used the FDA’s Adverse Event Reporting System (FAERS) database to summarize the adverse events reported to FDA by industry, medical professionals, and consumers.  We also assessed whether sipuleucel-T and specific adverse events (product-event pairs) were reported more than expected compared to all other drug/biologic-adverse event pairs in the FAERS database.

 MedicalResearch.com: What are the main findings? 

Response: Among 3,216 sipuleucel-T U.S. reports submitted to FAERS between April 29, 2010 and December 31, 2017, chills, malaise (general sense of not feeling well), pyrexia (fever), culture positive (blood, urine, or other cultures that suggest the possibility of an infection), fatigue, and nausea were the most commonly reported events.  Infusion-related reactions, infections, vascular events (blood clots), and transient ischemic attacks (TIAs) were among the adverse events reported more often than expected.  Overall, the reported adverse events following sipuleucel-T were consistent with the product label (package insert), and we did not identify new safety concerns.

MedicalResearch.com: What should readers take away from your report?

Response: The adverse events that were included on FAERS reports as well as those that were reported more than expected, are consistent with those described in the product insert.  We did not identify any new safety concerns associated with sipuleucel-T.

It is important to note that our analyses can only determine the relative frequency of reporting of adverse events in relation to adverse events reported to FAERS for all other products and cannot determine whether a specific adverse event was related to sipuleucel-T.

While this is the largest post-marketing study of safety and sipuleucel-T, our results should be considered in the context of study limitations, including underreporting of adverse events (reporting of adverse events is voluntary for health professionals and consumers), duplicate reporting, reporting biases (individuals with mild side effects may not submit a report to FAERS or to the manufacturer), and absence of information on the total number of patients treated with sipuleucel-T in the U.S.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response:  Our study serves to describe the types of adverse events that are reported to FAERS among men treated with sipuleucel-T.  Assessing the safety profile of a specific product can help health care professionals and consumers make personalized treatment decisions.  FDA will continue to monitor adverse events reported to FAERS to help ensure the safety of those who are treated with sipuleucel-T.  

MedicalResearch.com: Is there anything else you would like to add?

Response: We hope this study helps to further raise physician and consumer awareness of FAERS, and the importance of reporting adverse events temporally associated with drugs and biologic agents to FAERS (https://www.accessdata.fda.gov/scripts/medwatch/). 


Dores GM, Bryant-Genevier M, Perez-Vilar S. Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017. JAMA Netw Open. Published online August 14, 20192(8):e199249. doi:10.1001/jamanetworkopen.2019.9249


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Last Updated on August 15, 2019 by Marie Benz MD FAAD