# Sipuleucel-T

Source: https://onco.cc/drugs/sipuleucel-t/  
OnCo record `sipuleucel-t` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sipuleucel-T was the first therapeutic cancer vaccine approved (2010): it lengthened survival in metastatic prostate cancer by about four months without shrinking tumours or lowering PSA.

## Summary

IMPACT (NEJM 2010): OS 25.8 vs 21.7 months in asymptomatic/minimally symptomatic mCRPC. Cost, logistics (three leukaphereses) and absence of PSA/radiographic response limited uptake; Dendreon went bankrupt in 2014. Remains NCCN-listed for low-volume mCRPC and a proof of principle for cancer vaccines.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Provenge
- Modality: Autologous cellular immunotherapy (antigen-presenting cell vaccine)
- Mechanism: Patient's leukapheresed APCs are cultured with PA2024 (prostatic acid phosphatase fused to GM-CSF) and reinfused to prime PAP-specific T cells.
- Approvals: US 2010: Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer; EU 2013: Same (withdrawn 2015 for commercial reasons)

## Notes

- Sipuleucel-T was the first therapeutic cancer vaccine approved anywhere, on the strength of IMPACT: median overall survival 25.8 against 21.7 months, hazard ratio 0.78 (95 percent confidence interval 0.61 to 0.98, p=0.03), with no difference in time to objective disease progression. It is not available in England: NICE TA332 has been withdrawn because the marketing authorisation was withdrawn. Dendreon, which made it, filed for bankruptcy in 2014; the manufacturing burden of a per-patient autologous product was never recovered in sales.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Sipuleucel-T
- IMPACT (NEJM 2010): https://doi.org/10.1056/NEJMoa1001294
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=sipuleucel
- IMPACT (New England Journal of Medicine 2010): https://doi.org/10.1056/NEJMoa1001294
- NICE TA332: sipuleucel-T for asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer, guidance withdrawn: https://www.nice.org.uk/guidance/ta332

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Dendritic cell vaccines](https://onco.cc/technologies/dendritic-cell-vaccines/), [Off-the-shelf cancer vaccines](https://onco.cc/technologies/shared-antigen-vaccine/)
- companies: [Dendreon](https://onco.cc/companies/dendreon/)
- terms: [Cancer vaccines and oncolytic viruses](https://onco.cc/terms/vaccines-and-oncolytic-viruses/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/)
- trials: [IMPACT (sipuleucel-T)](https://onco.cc/trials/impact-sipuleucel-t/), [Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T](https://onco.cc/trials/nct06134232/)
- key papers: [Sipuleucel-T immunotherapy for castration-resistant prostate cancer](https://onco.cc/key-papers/paper-kantoff-n-engl-j-med/)
- targets: [Prostatic acid phosphatase (ACP3, PAP)](https://onco.cc/targets/pap/)

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