OnCo
drugsProductNot mapped hereapproved

Sipuleucel-T

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.

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.

Schematic of the modality · Autologous cellular immunotherapy (antigen-presenting cell vaccine) · not a molecule; see the Off-the-shelf cancer vaccines page
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.
Brand / code
Provenge
Medicare
Part B (clinician-administered)NCD 110.22

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. National coverage under NCD 110.22 for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer; HCPCS Q2043.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not recommendedNICE TA332 · 2015
Appraised for
Asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer
Notes
Never marketed in the UK; EU licence withdrawn 2015.

Sources: NICE TA332. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2010Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer
EU2013Same (withdrawn 2015 for commercial reasons)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
29 studies2 recruiting24 Phase 25 Phase 3
Search “Sipuleucel-T” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Sipuleucel-T
intervention: Sipuleucel-T
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Sipuleucel-T" OR ABSTRACT:"Sipuleucel-T" OR TITLE:"Provenge" OR ABSTRACT:"Provenge") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sipuleucel-T, not a curated reading list.

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