Lutetium-177 vipivotide tetraxetan
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.
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.
- 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 metastatic castration-resistant prostate cancer after ARPI and taxane (VISION)
- Notes
- Initially not recommended in draft guidance; NICE recommended it in 2025 after a revised commercial deal. Delivered at NHS nuclear medicine centres with PSMA PET selection. TA number not verified; follow the NICE search link.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: lutetium-177 vipivotide tetraxetan. 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 →
- 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) |
| 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
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Landmark trials in OnCo
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 (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.