# Lutetium-177 vipivotide tetraxetan

Source: https://nuclide.cc/drugs/pluvicto/  
Nuclide record `pluvicto` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.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: Agent
- 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%

## 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

## Connected records

- isotopes: [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Metastatic castration-resistant prostate cancer](https://nuclide.cc/indications/prostate-mcrpc/), [Metastatic hormone-sensitive prostate cancer](https://nuclide.cc/indications/prostate-mhspc/), [Prostate cancer](https://nuclide.cc/indications/prostate/)
- technologies: [Lutetium-177 radioligand therapy](https://nuclide.cc/technologies/lu177-radioligand-therapy/), [PSMA PET](https://nuclide.cc/technologies/psma-pet/), [Radioligand therapy (beta emitters)](https://nuclide.cc/technologies/radioligand-therapy/), [Radiopharmaceutical GMP and releasing a drug that decays](https://nuclide.cc/technologies/radiopharmaceutical-gmp-release/), [Research reactors for medical isotopes (Mo-99, Lu-177, I-131)](https://nuclide.cc/technologies/research-reactor-isotope-production/)
- targets: [PSMA](https://nuclide.cc/targets/psma/)
- companies: [Advanced Accelerator Applications (Novartis)](https://nuclide.cc/companies/advanced-accelerator-applications/), [Novartis](https://nuclide.cc/companies/novartis/)
- trials: [An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC](https://nuclide.cc/trials/nct06894511/), [ENZA-p](https://nuclide.cc/trials/enza-p/), [LuTectomy](https://nuclide.cc/trials/lutectomy/), [ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC](https://nuclide.cc/trials/nct05682443/), [PRINCE](https://nuclide.cc/trials/prince-trial/), [PSMAddition](https://nuclide.cc/trials/psmaddition/), [PSMAfore](https://nuclide.cc/trials/psmafore/), [Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function](https://nuclide.cc/trials/nct06004661/), [TheraP (ANZUP 1603)](https://nuclide.cc/trials/therap/), [UpFrontPSMA](https://nuclide.cc/trials/upfront-psma/), [VISION](https://nuclide.cc/trials/vision/)
- people: [A. Oliver Sartor](https://nuclide.cc/people/oliver-sartor/), [Amir Iravani](https://nuclide.cc/people/amir-iravani/), [Johannes Czernin](https://nuclide.cc/people/johannes-czernin/), [Ken Herrmann](https://nuclide.cc/people/ken-herrmann/), [Louise Emmett](https://nuclide.cc/people/louise-emmett/), [Michael Hofman](https://nuclide.cc/people/hofman-michael/), [Michael J. Morris](https://nuclide.cc/people/michael-morris/), [Phillip H. Kuo](https://nuclide.cc/people/phillip-kuo/), [Rahul Aggarwal](https://nuclide.cc/people/rahul-aggarwal/), [Rodney J. Hicks](https://nuclide.cc/people/rodney-hicks/), [Scott T. Tagawa](https://nuclide.cc/people/scott-tagawa/), [Shahneen Sandhu](https://nuclide.cc/people/sandhu-shahneen/), [Uwe Haberkorn](https://nuclide.cc/people/uwe-haberkorn/)
- drugs: [Illuccix (kit for Ga-68 gozetotide)](https://nuclide.cc/drugs/illuccix/), [Locametz (kit for Ga-68 gozetotide)](https://nuclide.cc/drugs/locametz/), [Lutetium-177 PNT2002](https://nuclide.cc/drugs/lu-177-pnt2002/), [Lutetium-177 rosopatamab tetraxetan](https://nuclide.cc/drugs/tlx-591/)
- institutions: [ANZUP Cancer Trials Group](https://nuclide.cc/institutions/anzup/), [European Association of Nuclear Medicine](https://nuclide.cc/institutions/eanm/), [Inselspital, Bern University Hospital / University Cancer Center Inselspital](https://nuclide.cc/institutions/inselspital-bern/), [IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)](https://nuclide.cc/institutions/irst-meldola/), [Peter MacCallum Cancer Centre](https://nuclide.cc/institutions/peter-mac/), [Society of Nuclear Medicine and Molecular Imaging](https://nuclide.cc/institutions/snmmi/), [TUM Klinikum rechts der Isar / CCC München](https://nuclide.cc/institutions/tum-munich/), [University Hospital Düsseldorf / CIO Düsseldorf](https://nuclide.cc/institutions/uk-duesseldorf/), [West German Cancer Center (WTZ), University Hospital Essen](https://nuclide.cc/institutions/essen-wtz/)
- pathways: [Prostate cancer (KEGG map)](https://nuclide.cc/pathways/prostate-cancer-signalling/)
- pairings: [177Lu-PSMA-617 (Pluvicto) with olaparib](https://nuclide.cc/pairings/pluvicto-plus-olaparib/), [177Lu-PSMA-617 then 225Ac-PSMA rescue therapy](https://nuclide.cc/pairings/beta-psma-then-alpha-psma-rescue/), [Beta radioligand → alpha radioligand](https://nuclide.cc/pairings/beta-then-alpha/), [Docetaxel (taxane chemotherapy) then 177Lu-PSMA-617](https://nuclide.cc/pairings/docetaxel-then-lu177-psma/), [PSMA PET → PSMA radioligand therapy](https://nuclide.cc/pairings/psma-pet-to-rlt/)
- roadmaps: [Dosimetry roadmap: MIRD schema → fixed dosing → personalised, image-based dose](https://nuclide.cc/roadmaps/dosimetry-roadmap/), [Isotope supply roadmap: reactor dependence → non-uranium production → accelerator-made actinium](https://nuclide.cc/roadmaps/isotope-supply-roadmap/), [PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha](https://nuclide.cc/roadmaps/psma-theranostics-roadmap/), [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://nuclide.cc/roadmaps/radiopharma-roadmap/)
- ideas: [A single-molecule copper-64/copper-67 pair instead of switching ligands between scan and treatment](https://nuclide.cc/ideas/idea-copper-theranostic-pair-standard/), [Adding a checkpoint inhibitor to PSMA radioligand therapy](https://nuclide.cc/ideas/idea-rlt-plus-checkpoint-inhibitor/), [Adding a PARP inhibitor to PSMA radioligand therapy](https://nuclide.cc/ideas/idea-rlt-plus-parp-inhibitor/), [Alpha-emitting PSMA therapy at first metastatic diagnosis](https://nuclide.cc/ideas/idea-alpha-first-mhspc/), [Alpha-emitting PSMA therapy for oligometastatic (few-lesion) prostate cancer](https://nuclide.cc/ideas/idea-alpha-for-oligometastatic-disease/), [Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier](https://nuclide.cc/ideas/idea-reg-yb176-enrichment-capacity/), [Kidney-dosimetry-guided dosing as the default for PSMA radioligand therapy](https://nuclide.cc/ideas/idea-dosimetry-guided-dosing-standard/), [Neoadjuvant PSMA radioligand therapy before prostatectomy](https://nuclide.cc/ideas/idea-neoadjuvant-psma-therapy/), [Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes](https://nuclide.cc/ideas/idea-reg-regional-radiopharmacy-hubs/), [Total-body PET for personalised radioligand dosing](https://nuclide.cc/ideas/idea-total-body-pet-dosimetry/)
- collections: [Prostate Cancer Foundation (PCF)](https://nuclide.cc/collections/prostate-cancer-foundation/)
- bottlenecks: [Clinical trial capacity for radioligand therapy](https://nuclide.cc/bottlenecks/b-rlt-trial-capacity/), [Dosimetry standardisation for radioligand therapy](https://nuclide.cc/bottlenecks/b-dosimetry-standardisation/), [Enriched target material for therapeutic isotopes](https://nuclide.cc/bottlenecks/b-enriched-target-material/), [Hot lab and shielded treatment room capacity](https://nuclide.cc/bottlenecks/b-hot-lab-capacity/), [Manufacturing cost and time for living and radioactive medicines](https://nuclide.cc/bottlenecks/b-manufacturing-cell-therapy/), [Radioactive waste handling and disposal regulation](https://nuclide.cc/bottlenecks/b-radioactive-waste-regulation/), [Reimbursement and coding for radiopharmaceuticals](https://nuclide.cc/bottlenecks/b-reimbursement-coding/), [Site readiness and referral pathway delays](https://nuclide.cc/bottlenecks/b-site-readiness-referral/)
- key papers: [EANM dosimetry committee recommendations for dosimetry of 177Lu-labelled somatostatin-receptor- and PSMA-targeting ligands](https://nuclide.cc/key-papers/paper-eanm-lu177-dosimetry-recommendations-ejnmmi-2022/), [PSMAfore: 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor in taxane-naive mCRPC](https://nuclide.cc/key-papers/paper-psmafore-lancet-2024/), [TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer](https://nuclide.cc/key-papers/paper-therap-lancet-2021/), [VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer](https://nuclide.cc/key-papers/paper-vision-nejm-2021/)
- fronts: [Radioligand therapy](https://nuclide.cc/fronts/f-radioligand-therapy/)
- terms: [Fixed versus personalised (dosimetry-guided) dosing](https://nuclide.cc/terms/fixed-versus-personalised-dosing/), [Myelosuppression after radioligand therapy](https://nuclide.cc/terms/myelosuppression-after-rlt/), [Patient release criteria after radioactive treatment](https://nuclide.cc/terms/patient-release-criteria/), [PSMA-RADS (PSMA reporting and data system)](https://nuclide.cc/terms/psma-rads/), [Salivary gland toxicity (xerostomia) from PSMA radioligand therapy](https://nuclide.cc/terms/salivary-gland-toxicity/), [Theranostic pair](https://nuclide.cc/terms/theranostic-pair-term/)

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