{"entity":{"id":"pylarify","kind":"drug","name":"Piflufolastat F-18 / Pylarify TruVu","aka":["Piflufolastat (18F)","Pylclari"],"tldr":"Piflufolastat F-18 (Pylarify) is the leading PSMA PET tracer for prostate cancer, with a new formulation approved in March 2026.","summary":"Piflufolastat F-18 is a PET tracer: an 18F-labelled urea that binds prostate-specific membrane antigen (PSMA), lighting up prostate cancer deposits that conventional CT and bone scan miss. It was approved in 2021 for PSMA PET in initial staging and biochemical recurrence, and Lantheus' Pylarify TruVu formulation, approved on 9 March 2026, offers an improved formulation and distribution profile. A single 333 MBq dose is injected and imaging follows 60 to 120 minutes later; adverse effects are minor. The 18F label allows central manufacture and shipping, unlike generator-produced 68Ga agents, and it competes with Illuccix/Gozellix (68Ga, Telix), Locametz (Novartis) and Posluma. The open question is whether the management changes PSMA PET triggers translate into longer survival. For a newcomer: the leading tracer for seeing where prostate cancer actually is.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Piflufolastat_F-18","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Piflufolastat%20F-18"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":["psma-pet"],"targets":["psma"],"drugs":[],"companies":["lantheus"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03739684","nct04457245","nct02981368"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Pylarify","code":"18F-DCFPyL","modality":"PET imaging agent","mechanism":"18F-labelled PSMA-binding urea.","approvals":[{"region":"US","year":2021,"indication":"PSMA PET imaging in prostate cancer"},{"region":"US","year":2026,"indication":"Pylarify TruVu formulation"},{"region":"EU","year":2023,"indication":"EU brand Pylclari (Curium)"}],"mechanismSteps":["18F-labelled small molecule binds the PSMA active site","Tracer is internalised and retained in prostate cancer cells","Positron emissions are detected by the PET scanner","Whole-body map of PSMA-expressing disease is produced","Result selects patients for PSMA radioligand therapy"],"dosing":{"route":"IV injection (diagnostic)","schedule":"333 MBq (9 mCi) single dose; imaging 60-120 minutes later","monitoring":"Hydration and voiding to reduce bladder dose","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Headache","note":"Rare; diagnostic dose"},{"event":"Dysgeusia"},{"event":"Fatigue"}],"access":[{"country":"US","reimbursement":"Medicare pass-through/payment for PSMA PET; broad commercial coverage for staging and biochemical recurrence","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2021-05-26","type":"approval","region":"US","note":"PSMA PET imaging in prostate cancer: first 18F PSMA agent","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-03-09","type":"approval","region":"US","note":"Pylarify TruVu formulation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/pylarify/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"curium","kind":"company","name":"Curium","route":"/companies/curium/"},{"id":"lantheus","kind":"company","name":"Lantheus","route":"/companies/lantheus/"}],"trial":[{"id":"nct04457245","kind":"trial","name":"Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer","route":"/trials/nct04457245/"},{"id":"nct02981368","kind":"trial","name":"Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer","route":"/trials/nct02981368/"},{"id":"nct03739684","kind":"trial","name":"Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer","route":"/trials/nct03739684/"}],"pairing":[{"id":"psma-pet-to-rlt","kind":"pairing","name":"PSMA PET → PSMA radioligand therapy","route":"/pairings/psma-pet-to-rlt/"}],"roadmap":[{"id":"molecular-imaging-roadmap","kind":"roadmap","name":"Molecular imaging roadmap: FDG → PSMA → FAP → antigen and immune PET","route":"/roadmaps/molecular-imaging-roadmap/"},{"id":"radiopharma-roadmap","kind":"roadmap","name":"Radiopharmaceutical roadmap: iodine → lutetium → actinium","route":"/roadmaps/radiopharma-roadmap/"}],"institution":[{"id":"snmmi","kind":"institution","name":"Society of Nuclear Medicine and Molecular Imaging","route":"/institutions/snmmi/"}],"drug":[{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","route":"/drugs/illuccix/"}],"biomarker":[{"id":"psma-pet-expression","kind":"biomarker","name":"PSMA expression by PET (PSMA-positive)","route":"/biomarkers/psma-pet-expression/"}]}}