# Lutetium-177 vipivotide tetraxetan

Source: https://onco.cc/drugs/pluvicto/  
OnCo record `pluvicto` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A radioactive drug that seeks out PSMA on prostate cancer cells; the best-selling radiopharmaceutical ever.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Pluvicto
- Code: 177Lu-PSMA-617
- Modality: Radioligand therapy (beta)
- Mechanism: Small-molecule PSMA ligand chelated to 177Lu; beta emission with 2 mm range.
- Approvals: 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
- Dosing: IV injection; 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses
- Toxicity (grade 3+): Lymphocytes decreased 47%; Haemoglobin decreased 15%; Platelets decreased 9%

## Notes

- NICE TA930 does not recommend lutetium-177 vipivotide tetraxetan in England for PSMA-positive hormone-relapsed metastatic prostate cancer after taxane-based chemotherapy and an anti-androgen, or where taxanes are medically unsuitable, despite accepting that it extends both progression-free and overall survival against best supportive care. The committee could not consider the comparison with radium-223 because no such evidence was submitted. Men whose treatment started before publication are unaffected.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Lutetium_(177Lu)_vipivotide_tetraxetan
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lutetium-177%20vipivotide%20tetraxetan
- NICE TA930: lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments, not recommended: https://www.nice.org.uk/guidance/ta930

## Connected records

- biomarkers: [PSMA expression by PET (PSMA-positive)](https://onco.cc/biomarkers/psma-pet-expression/)
- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Lutetium-177 radioligand therapy](https://onco.cc/technologies/lu177-radioligand-therapy/), [PSMA PET](https://onco.cc/technologies/psma-pet/), [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/), [Radiopharmaceutical GMP and releasing a drug that decays](https://onco.cc/technologies/radiopharmaceutical-gmp-release/), [Research reactors for medical isotopes (Mo-99, Lu-177, I-131)](https://onco.cc/technologies/research-reactor-isotope-production/)
- targets: [PSMA](https://onco.cc/targets/psma/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/), [ANZUP Cancer Trials Group](https://onco.cc/companies/anzup/), [Novartis](https://onco.cc/companies/novartis/)
- terms: [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [What follows what in castration-resistant prostate cancer](https://onco.cc/terms/prostate-crpc-sequencing/)
- trials: [An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC](https://onco.cc/trials/nct06894511/), [ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC](https://onco.cc/trials/nct05682443/), [PSMAddition](https://onco.cc/trials/psmaddition/), [PSMAfore](https://onco.cc/trials/psmafore/), [Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function](https://onco.cc/trials/nct06004661/), [TheraP (ANZUP 1603)](https://onco.cc/trials/therap/), [VISION](https://onco.cc/trials/vision/)
- people: [A. Oliver Sartor](https://onco.cc/people/oliver-sartor/), [Johannes Czernin](https://onco.cc/people/johannes-czernin/), [Ken Herrmann](https://onco.cc/people/ken-herrmann/), [Louise Emmett](https://onco.cc/people/louise-emmett/), [Michael Hofman](https://onco.cc/people/hofman-michael/), [Michael J. Morris](https://onco.cc/people/michael-morris/), [Rahul Aggarwal](https://onco.cc/people/rahul-aggarwal/), [Shahneen Sandhu](https://onco.cc/people/sandhu-shahneen/), [Uwe Haberkorn](https://onco.cc/people/uwe-haberkorn/)
- ideas: [Alpha-emitting PSMA therapy at first metastatic diagnosis](https://onco.cc/ideas/idea-alpha-first-mhspc/), [Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier](https://onco.cc/ideas/idea-reg-yb176-enrichment-capacity/), [Randomise the order of treatment, not only the drugs: a strategy platform for metastatic prostate cancer](https://onco.cc/ideas/idea-prostate-randomise-the-sequence-not-only-the-drugs/), [Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes](https://onco.cc/ideas/idea-reg-regional-radiopharmacy-hubs/), [Total-body PET for personalised radioligand dosing](https://onco.cc/ideas/idea-total-body-pet-dosimetry/)
- institutions: [Chulabhorn Hospital / Chulabhorn Royal Academy](https://onco.cc/institutions/chulabhorn-hospital/), [European Association of Nuclear Medicine](https://onco.cc/institutions/eanm/), [Inselspital, Bern University Hospital / University Cancer Center Inselspital](https://onco.cc/institutions/inselspital-bern/), [IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)](https://onco.cc/institutions/irst-meldola/), [Peter MacCallum Cancer Centre](https://onco.cc/institutions/peter-mac/), [Postgraduate Institute of Medical Education and Research, Chandigarh](https://onco.cc/institutions/pgimer-chandigarh/), [Purdue Institute for Cancer Research](https://onco.cc/institutions/purdue-cancer-research/), [Society of Nuclear Medicine and Molecular Imaging](https://onco.cc/institutions/snmmi/), [TUM Klinikum rechts der Isar / CCC München](https://onco.cc/institutions/tum-munich/), [University Hospital Düsseldorf / CIO Düsseldorf](https://onco.cc/institutions/uk-duesseldorf/), [West German Cancer Center (WTZ), University Hospital Essen](https://onco.cc/institutions/essen-wtz/)
- pairings: [Beta radioligand → alpha radioligand](https://onco.cc/pairings/beta-then-alpha/), [PSMA PET → PSMA radioligand therapy](https://onco.cc/pairings/psma-pet-to-rlt/)
- roadmaps: [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://onco.cc/roadmaps/radiopharma-roadmap/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)
- collections: [Prostate Cancer Foundation (PCF)](https://onco.cc/collections/prostate-cancer-foundation/)
- key papers: [VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer](https://onco.cc/key-papers/paper-vision-nejm-2021/)
- pathways: [Organ tropism: seed and soil](https://onco.cc/pathways/organ-tropism-seed-soil/), [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/)
- drugs: [Illuccix (kit for Ga-68 gozetotide)](https://onco.cc/drugs/illuccix/), [Locametz (kit for Ga-68 gozetotide)](https://onco.cc/drugs/locametz/)

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JSON: https://onco.cc/api/v1/entities/pluvicto.json