{"entity":{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Lutetium_(177Lu)_vipivotide_tetraxetan","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lutetium-177%20vipivotide%20tetraxetan"},{"label":"NICE TA930: lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments, not recommended","url":"https://www.nice.org.uk/guidance/ta930"}],"tags":[],"related":["psma-pet-expression"],"cancers":["prostate","prostate-mcrpc","prostate-mhspc"],"sections":[],"technologies":["radioligand-therapy","psma-pet"],"targets":["psma"],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["prostate-crpc-sequencing","prostate-uk-drug-approvals"],"trials":["vision","psmafore","nct05682443","nct06894511","nct06004661"],"people":["louise-emmett"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"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":[{"region":"US","year":2022,"indication":"PSMA+ mCRPC after ARPI and taxane"},{"region":"US","year":2025,"indication":"PSMA+ mCRPC after ARPI, before chemotherapy"},{"region":"US","year":2026,"indication":"Label expansion (July 2026)"},{"region":"EU","year":2022,"indication":"mCRPC post-ARPI and taxane; pre-chemo 2025"}],"mechanismSteps":["Radioligand circulates and binds PSMA on tumour cells","Ligand is internalised or retained at the membrane","Beta emissions deposit energy within a short range","Clustered DNA double-strand breaks form in the tumour cell and its neighbours (crossfire)","Cells die; unbound ligand is cleared via the kidneys"],"dosing":{"route":"IV injection","schedule":"7.4 GBq (200 mCi) every 6 weeks for up to 6 doses","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":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a"},"toxicity":[{"event":"Lymphocytes decreased","anyGradePct":85,"grade3PlusPct":47,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"},{"event":"Haemoglobin decreased","anyGradePct":64,"grade3PlusPct":15,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"},{"event":"Fatigue","anyGradePct":48,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"},{"event":"Dry mouth","anyGradePct":39,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"},{"event":"Nausea","anyGradePct":36,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"},{"event":"Decreased appetite","anyGradePct":21,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"},{"event":"Platelets decreased","grade3PlusPct":9,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a","note":"VISION"}],"access":[{"country":"US","listPrice":"~$42,500 per dose (Novartis, 2022 launch price)","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.novartis.com/us-en/patient-support","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for PSMA+ mCRPC after ARPI and taxane (2025); pre-chemotherapy appraisal in progress","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2021-06","type":"designation","region":"US","note":"Breakthrough Therapy designation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-03-23","type":"approval","region":"US","note":"PSMA+ mCRPC after ARPI and taxane (VISION)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-12","type":"approval","region":"EU","note":"EMA approval","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-03-28","type":"approval","region":"US","note":"PSMA+ mCRPC after ARPI, before chemotherapy (PSMAfore)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-07-31","type":"approval","region":"US","note":"PSMA+ metastatic hormone-sensitive prostate cancer with ARPI (PSMAddition)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/pluvicto/","neighbours":{"biomarker":[{"id":"psma-pet-expression","kind":"biomarker","name":"PSMA expression by PET (PSMA-positive)","route":"/biomarkers/psma-pet-expression/"}],"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"lu177-radioligand-therapy","kind":"technology","name":"Lutetium-177 radioligand therapy","route":"/technologies/lu177-radioligand-therapy/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"},{"id":"radiopharmaceutical-gmp-release","kind":"technology","name":"Radiopharmaceutical GMP and releasing a drug that decays","route":"/technologies/radiopharmaceutical-gmp-release/"},{"id":"research-reactor-isotope-production","kind":"technology","name":"Research reactors for medical isotopes (Mo-99, Lu-177, I-131)","route":"/technologies/research-reactor-isotope-production/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"},{"id":"anzup","kind":"company","name":"ANZUP Cancer Trials Group","route":"/companies/anzup/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"term":[{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"nct06894511","kind":"trial","name":"An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC","route":"/trials/nct06894511/"},{"id":"nct05682443","kind":"trial","name":"ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC","route":"/trials/nct05682443/"},{"id":"psmaddition","kind":"trial","name":"PSMAddition","route":"/trials/psmaddition/"},{"id":"psmafore","kind":"trial","name":"PSMAfore","route":"/trials/psmafore/"},{"id":"nct06004661","kind":"trial","name":"Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function","route":"/trials/nct06004661/"},{"id":"therap","kind":"trial","name":"TheraP (ANZUP 1603)","route":"/trials/therap/"},{"id":"vision","kind":"trial","name":"VISION","route":"/trials/vision/"}],"person":[{"id":"oliver-sartor","kind":"person","name":"A. Oliver Sartor","route":"/people/oliver-sartor/"},{"id":"johannes-czernin","kind":"person","name":"Johannes Czernin","route":"/people/johannes-czernin/"},{"id":"ken-herrmann","kind":"person","name":"Ken Herrmann","route":"/people/ken-herrmann/"},{"id":"louise-emmett","kind":"person","name":"Louise Emmett","route":"/people/louise-emmett/"},{"id":"hofman-michael","kind":"person","name":"Michael Hofman","route":"/people/hofman-michael/"},{"id":"michael-morris","kind":"person","name":"Michael J. Morris","route":"/people/michael-morris/"},{"id":"rahul-aggarwal","kind":"person","name":"Rahul Aggarwal","route":"/people/rahul-aggarwal/"},{"id":"sandhu-shahneen","kind":"person","name":"Shahneen Sandhu","route":"/people/sandhu-shahneen/"},{"id":"uwe-haberkorn","kind":"person","name":"Uwe Haberkorn","route":"/people/uwe-haberkorn/"}],"idea":[{"id":"idea-alpha-first-mhspc","kind":"idea","name":"Alpha-emitting PSMA therapy at first metastatic diagnosis","route":"/ideas/idea-alpha-first-mhspc/"},{"id":"idea-reg-yb176-enrichment-capacity","kind":"idea","name":"Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier","route":"/ideas/idea-reg-yb176-enrichment-capacity/"},{"id":"idea-prostate-randomise-the-sequence-not-only-the-drugs","kind":"idea","name":"Randomise the order of treatment, not only the drugs: a strategy platform for metastatic prostate cancer","route":"/ideas/idea-prostate-randomise-the-sequence-not-only-the-drugs/"},{"id":"idea-reg-regional-radiopharmacy-hubs","kind":"idea","name":"Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes","route":"/ideas/idea-reg-regional-radiopharmacy-hubs/"},{"id":"idea-total-body-pet-dosimetry","kind":"idea","name":"Total-body PET for personalised radioligand dosing","route":"/ideas/idea-total-body-pet-dosimetry/"}],"institution":[{"id":"chulabhorn-hospital","kind":"institution","name":"Chulabhorn Hospital / Chulabhorn Royal Academy","route":"/institutions/chulabhorn-hospital/"},{"id":"eanm","kind":"institution","name":"European Association of Nuclear Medicine","route":"/institutions/eanm/"},{"id":"inselspital-bern","kind":"institution","name":"Inselspital, Bern University Hospital / University Cancer Center Inselspital","route":"/institutions/inselspital-bern/"},{"id":"irst-meldola","kind":"institution","name":"IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)","route":"/institutions/irst-meldola/"},{"id":"peter-mac","kind":"institution","name":"Peter MacCallum Cancer Centre","route":"/institutions/peter-mac/"},{"id":"pgimer-chandigarh","kind":"institution","name":"Postgraduate Institute of Medical Education and Research, Chandigarh","route":"/institutions/pgimer-chandigarh/"},{"id":"purdue-cancer-research","kind":"institution","name":"Purdue Institute for Cancer Research","route":"/institutions/purdue-cancer-research/"},{"id":"snmmi","kind":"institution","name":"Society of Nuclear Medicine and Molecular Imaging","route":"/institutions/snmmi/"},{"id":"tum-munich","kind":"institution","name":"TUM Klinikum rechts der Isar / CCC München","route":"/institutions/tum-munich/"},{"id":"uk-duesseldorf","kind":"institution","name":"University Hospital Düsseldorf / CIO Düsseldorf","route":"/institutions/uk-duesseldorf/"},{"id":"essen-wtz","kind":"institution","name":"West German Cancer Center (WTZ), University Hospital Essen","route":"/institutions/essen-wtz/"}],"pairing":[{"id":"beta-then-alpha","kind":"pairing","name":"Beta radioligand → alpha radioligand","route":"/pairings/beta-then-alpha/"},{"id":"psma-pet-to-rlt","kind":"pairing","name":"PSMA PET → PSMA radioligand therapy","route":"/pairings/psma-pet-to-rlt/"}],"roadmap":[{"id":"radiopharma-roadmap","kind":"roadmap","name":"Radiopharmaceutical roadmap: iodine → lutetium → actinium","route":"/roadmaps/radiopharma-roadmap/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"}],"collection":[{"id":"prostate-cancer-foundation","kind":"collection","name":"Prostate Cancer Foundation (PCF)","route":"/collections/prostate-cancer-foundation/"}],"paper":[{"id":"paper-vision-nejm-2021","kind":"paper","name":"VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer","route":"/key-papers/paper-vision-nejm-2021/"}],"pathway":[{"id":"organ-tropism-seed-soil","kind":"pathway","name":"Organ tropism: seed and soil","route":"/pathways/organ-tropism-seed-soil/"},{"id":"prostate-cancer-signalling","kind":"pathway","name":"Prostate cancer (KEGG map)","route":"/pathways/prostate-cancer-signalling/"}],"drug":[{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","route":"/drugs/illuccix/"},{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/"}]}}