Author Interviews, Cancer Research, FDA, Vaccine Studies / 14.08.2019
FDA Identifies No New Safety Concerns Associated with Prostate Cancer Treatment Vaccine Sipuleucel-T
MedicalResearch.com Interview with:
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.
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