{"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"}],"tags":[],"related":["lu-177"],"indications":["prostate","prostate-mcrpc","prostate-mhspc"],"sections":[],"technologies":["radioligand-therapy","psma-pet"],"targets":["psma"],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":["vision","psmafore","nct05682443","nct06894511","nct06004661"],"people":["louise-emmett"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":{"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"},{"id":"prostate-mhspc","kind":"indication","name":"Metastatic hormone-sensitive prostate cancer","route":"/indications/prostate-mhspc/"},{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/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":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"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":"enza-p","kind":"trial","name":"ENZA-p","route":"/trials/enza-p/"},{"id":"lutectomy","kind":"trial","name":"LuTectomy","route":"/trials/lutectomy/"},{"id":"nct05682443","kind":"trial","name":"ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC","route":"/trials/nct05682443/"},{"id":"prince-trial","kind":"trial","name":"PRINCE","route":"/trials/prince-trial/"},{"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":"upfront-psma","kind":"trial","name":"UpFrontPSMA","route":"/trials/upfront-psma/"},{"id":"vision","kind":"trial","name":"VISION","route":"/trials/vision/"}],"person":[{"id":"oliver-sartor","kind":"person","name":"A. 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