A radioactive drug that seeks out PSMA on prostate cancer cells; the best-selling radiopharmaceutical ever.
VISION (2021): OS 15.3 vs 11.3 months in post-chemotherapy mCRPC. PSMAfore (2023) led to a 2025 label before chemotherapy. July 2026 FDA action further expanded the label (per AACR/FDA roundups). PSMAddition tests it in hormone-sensitive disease. Requires PSMA PET positivity. Six cycles every 6 weeks; xerostomia, cytopenias, renal monitoring.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Small-molecule PSMA ligand chelated to 177Lu; beta emission with 2 mm range. Connects to PSMA.
1.Radioligand circulates and binds PSMA on tumour cells
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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. Radioligand therapy given in nuclear medicine; HCPCS A9607. Paid separately under the hospital outpatient system; the six-dose course is spread over about eight months, so coinsurance recurs with each dose.
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. PSMA-positive disease on an approved PET scan, and prior androgen receptor pathway inhibitor (taxane no longer required since the 2025 label expansion).
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 TA930 · SMC advice: lutetium-177 vipivotide tetraxetan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Novartis announced the supplemental filing after the PSMAddition results in 2025. No action date has been disclosed; the year is our estimate. Source
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Breakthrough Therapy designation source
PSMA+ mCRPC after ARPI and taxane (VISION) source
EMA approval source
PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore) source
PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition) source
| Region | Year | Indication |
|---|---|---|
| US | 2022 | PSMA+ mCRPC after ARPI and taxane |
| US | 2025 | PSMA+ mCRPC after ARPI, before chemotherapy |
| US | 2026 | Label expansion (July 2026) |
| EU | 2022 | mCRPC post-ARPI and taxane; pre-chemo 2025 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Lymphocytes decreased | 85% | 47% |
| Haemoglobin decreased | 64% | 15% |
| Fatigue | 48% | - |
| Dry mouth | 39% | - |
| Nausea | 36% | - |
| Decreased appetite | 21% | - |
| Platelets decreased | - | 9% |
VISION. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | ~$42,500 per dose (Novartis, 2022 launch price) | novartis.com/us-en/patient-support |
| United Kingdom | NICE: recommended for PSMA+ mCRPC after ARPI and taxane (2025); pre-chemotherapy appraisal in progress | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Lutetium-177 vipivotide tetraxetan" OR ABSTRACT:"Lutetium-177 vipivotide tetraxetan" OR TITLE:"Pluvicto" OR ABSTRACT:"Pluvicto" OR TITLE:"177Lu-PSMA-617" OR ABSTRACT:"177Lu-PSMA-617") 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 Lutetium-177 vipivotide tetraxetan, not a curated reading list.
Shares Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes, PSMA PET → PSMA radioligand therapy, Chulabhorn Hospital / Chulabhorn Royal Academy, Locametz (kit for Ga-68 gozetotide).
Shares Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes, Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier, Beta radioligand → alpha radioligand, Chulabhorn Hospital / Chulabhorn Royal Academy.
Shares Alpha-emitting PSMA therapy at first metastatic diagnosis, Total-body PET for personalised radioligand dosing, IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST), European Association of Nuclear Medicine.
Shares PSMA expression by PET (PSMA-positive), TheraP (ANZUP 1603), VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer, Randomise the order of treatment, not only the drugs: a strategy platform for metastatic prostate cancer.
Shares Alpha-emitting PSMA therapy at first metastatic diagnosis, Beta radioligand → alpha radioligand, PSMA expression by PET (PSMA-positive), Radiopharmaceutical roadmap: iodine → lutetium → actinium.
Shares PSMA PET → PSMA radioligand therapy, Illuccix (kit for Ga-68 gozetotide), Society of Nuclear Medicine and Molecular Imaging, PSMA expression by PET (PSMA-positive).
Shares Michael Hofman, Prostate Cancer Foundation (PCF), ANZUP Cancer Trials Group, Peter MacCallum Cancer Centre.
Shares Michael Hofman, Uwe Haberkorn, Radiopharmaceutical roadmap: iodine → lutetium → actinium, Peter MacCallum Cancer Centre.