Lutetium-177 vipivotide tetraxetan
A radioactive drug that seeks out PSMA on prostate cancer cells; the best-selling radiopharmaceutical ever.
Overview
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
PubChem holds the unlabelled ligand, so the radionuclide itself is not in this drawing.
Small-molecule PSMA ligand chelated to 177Lu; beta emission with 2 mm range. Connects to PSMA.
- PSMA / SSTR-positive cell
1.Radioligand circulates and binds PSMA on tumour cells
- Route
- IV injection
- Schedule
- 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses
- Dose modifications
- Hold for grade ≥3 myelosuppression or renal impairment; permanently discontinue for grade 4 haematologic toxicity
- Monitoring
- Blood counts and renal function before each dose; hydration; radiation-protection instructions for 7 days
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- PSMA PET (Ga-68 PSMA-11, F-18 piflufolastat, F-18 flotufolastat) · At least one PSMA-positive lesion and no dominant PSMA-negative lesion (VISION criteria) for lutetium-177 PSMA-617
- Medicare
- Part B (clinician-administered)
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.
- 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. PSMA-positive disease on an approved PET scan, and prior androgen receptor pathway inhibitor (taxane no longer required since the 2025 label expansion).
- Assistance programmes
- Novartis Patient Support (Patient Assistance NOW Oncology)
- PAN Foundation: Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments (VISION)
- Notes
- TA930, published 15 November 2023, does not recommend it: the cost-effectiveness estimates were above the range NICE considers an acceptable use of NHS resources, and the committee also concluded it was not suitable for the Cancer Drugs Fund. A second evaluation, of use after an anti-androgen but before a taxane, was terminated on 16 July 2026 because the company made no evidence submission (TA1179). Individual funding requests and a resubmission remain possible.
Sources: NICE TA930. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Deals
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- Jun 2021DesignationUS
Breakthrough Therapy designation source
- 23 Mar 2022ApprovalUS
PSMA+ mCRPC after ARPI and taxane (VISION) source
- Dec 2022ApprovalEU
EMA approval source
- 28 Mar 2025ApprovalUS
PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore) source
- 31 Jul 2026ApprovalUS
PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition) source
Approvals
| 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.
Trials
topTrials recruiting now
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Landmark trials
For men who still have a working hormone treatment option but whose cancer is progressing, offering the PSMA radioligand therapy sooner - before chemotherapy - delayed disease progression, though it did not clearly extend how long men lived once the very high rate of patients switching over is accounted for.
This document standardises how hospitals measure the actual radiation dose reaching a patient's kidneys and tumours during lutetium-177 treatment, laying the groundwork for shifting from a one-dose-fits-all schedule to treatment doses tailored to each patient's biology.
For men whose prostate cancer has grown after chemotherapy, a PSMA-targeted radioactive treatment worked at least as well as, and was gentler than, the chemotherapy drug it replaced - provided a PET scan first confirms the cancer takes up the PSMA tracer.
Men with metastatic castration-resistant prostate cancer that has progressed after hormonal therapy and chemotherapy, and whose tumours show PSMA on a PET scan, can now receive lutetium-PSMA, which extends life, controls pain and is usually better tolerated than further chemotherapy. It has established a new treatment class in which a scan decides who gets the matching radioactive drug, and it is now being tested earlier in the disease (PSMAfore, PSMAddition).
Latest papers
topQuery 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 (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR 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.
Similar pages
not linked directly; found by shared links- AgentLutetium-177 dotatate
Shares Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes, Radioactive waste handling and disposal regulation, Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier, West German Cancer Center (WTZ), University Hospital Essen.
- TermTheranostics
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- TermDosimetry
Shares EANM dosimetry committee recommendations for dosimetry of 177Lu-labelled somatostatin-receptor- and PSMA-targeting ligands, Alpha-emitting PSMA therapy at first metastatic diagnosis, Inselspital, Bern University Hospital / University Cancer Center Inselspital, IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST).
- AgentActinium-225 PSMA agents
Shares Alpha-emitting PSMA therapy for oligometastatic (few-lesion) prostate cancer, 177Lu-PSMA-617 then 225Ac-PSMA rescue therapy, Alpha-emitting PSMA therapy at first metastatic diagnosis, Beta radioligand → alpha radioligand.
- Agent177Lu-PSMA-I&T
Shares Salivary gland toxicity (xerostomia) from PSMA radioligand therapy, Lutetium-177 PNT2002, PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha, Research reactors for medical isotopes (Mo-99, Lu-177, I-131).
- IsotopeActinium-225
Shares Alpha-emitting PSMA therapy for oligometastatic (few-lesion) prostate cancer, Adding a PARP inhibitor to PSMA radioligand therapy, 177Lu-PSMA-617 (Pluvicto) with olaparib, 177Lu-PSMA-617 then 225Ac-PSMA rescue therapy.
- AgentGallium-68 gozetotide (PSMA-11)
Shares PSMA-RADS (PSMA reporting and data system), Theranostic pair, Illuccix (kit for Ga-68 gozetotide), Locametz (kit for Ga-68 gozetotide).
- AgentPiflufolastat F-18 / Pylarify TruVu
Shares PSMA-RADS (PSMA reporting and data system), PSMA PET → PSMA radioligand therapy, Reimbursement and coding for radiopharmaceuticals, Illuccix (kit for Ga-68 gozetotide).