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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.
Patient's leukapheresed APCs are cultured with PA2024 (prostatic acid phosphatase fused to GM-CSF) and reinfused to prime PAP-specific T cells.
1.Sipuleucel-T slips into a pocket on its target.
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.
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.
Sources: NICE TA332. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| US | 2010 | Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer |
| EU | 2013 | Same (withdrawn 2015 for commercial reasons) |
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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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