{"entity":{"id":"sipuleucel-t","kind":"drug","name":"Sipuleucel-T","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Sipuleucel-T","links":[{"label":"IMPACT (NEJM 2010)","url":"https://doi.org/10.1056/NEJMoa1001294"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=sipuleucel"},{"label":"IMPACT (New England Journal of Medicine 2010)","url":"https://doi.org/10.1056/NEJMoa1001294"},{"label":"NICE TA332: sipuleucel-T for asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer, guidance withdrawn","url":"https://www.nice.org.uk/guidance/ta332"}],"tags":["gap-fill"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":[],"companies":["dendreon"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["nct06134232","impact-sipuleucel-t"],"people":[],"bottlenecks":[],"keyPapers":["paper-kantoff-n-engl-j-med"],"journals":[],"dependsOn":[],"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 It is not available in England: NICE TA332 has been withdrawn because the marketing authorisation was withdrawn.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."],"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":[{"region":"US","year":2010,"indication":"Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer"},{"region":"EU","year":2013,"indication":"Same (withdrawn 2015 for commercial reasons)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/sipuleucel-t/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"dendritic-cell-vaccines","kind":"technology","name":"Dendritic cell vaccines","route":"/technologies/dendritic-cell-vaccines/"},{"id":"shared-antigen-vaccine","kind":"technology","name":"Off-the-shelf cancer vaccines","route":"/technologies/shared-antigen-vaccine/"}],"company":[{"id":"dendreon","kind":"company","name":"Dendreon","route":"/companies/dendreon/"}],"term":[{"id":"vaccines-and-oncolytic-viruses","kind":"term","name":"Cancer vaccines and oncolytic viruses","route":"/terms/vaccines-and-oncolytic-viruses/"},{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"}],"trial":[{"id":"impact-sipuleucel-t","kind":"trial","name":"IMPACT (sipuleucel-T)","route":"/trials/impact-sipuleucel-t/"},{"id":"nct06134232","kind":"trial","name":"Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T","route":"/trials/nct06134232/"}],"paper":[{"id":"paper-kantoff-n-engl-j-med","kind":"paper","name":"Sipuleucel-T immunotherapy for castration-resistant prostate cancer","route":"/key-papers/paper-kantoff-n-engl-j-med/"}],"target":[{"id":"pap","kind":"target","name":"Prostatic acid phosphatase (ACP3, PAP)","route":"/targets/pap/"}]}}