{"entity":{"id":"flotufolastat","kind":"drug","name":"Flotufolastat F-18","aka":[],"tldr":"Flotufolastat is a third PSMA PET tracer, with a radiohybrid chemistry designed to be reused for therapy.","summary":"Flotufolastat F-18 (Posluma) is a radiohybrid PSMA ligand: a silicon-fluoride acceptor allows 18F labelling for PET while the same scaffold can carry 177Lu for therapy, so imaging and treatment agents share one chemistry. It is used for PSMA PET in men with prostate cancer at initial staging and at biochemical recurrence. The LIGHTHOUSE (initial staging) and SPOTLIGHT (biochemical recurrence) trials supported approval in May 2023. Low urinary excretion aids reading of the pelvis, where bladder activity can obscure local recurrence with other tracers. It is the third PSMA PET tracer in the US after gallium-68 PSMA-11 and Pylarify, and head-to-head comparisons are limited. For a newcomer, it is a PSMA scan agent designed from the start to be reused for therapy.","status":"approved","asOf":"2026-09-06","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Flotufolastat%20F-18"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":["psma-pet"],"targets":["psma"],"drugs":[],"companies":["blue-earth-diagnostics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07285057","nct07455903","nct06617481"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Posluma","code":"18F-rhPSMA-7.3","modality":"PET imaging agent","mechanism":"Radiohybrid PSMA ligand; silicon-fluoride acceptor allows 18F imaging and 177Lu therapy on the same scaffold.","approvals":[{"region":"US","year":2023,"indication":"PSMA PET in prostate cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/flotufolastat/","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":"blue-earth-diagnostics","kind":"company","name":"Blue Earth Diagnostics (Bracco)","route":"/companies/blue-earth-diagnostics/"}],"trial":[{"id":"nct07455903","kind":"trial","name":"Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT","route":"/trials/nct07455903/"},{"id":"nct07285057","kind":"trial","name":"Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance","route":"/trials/nct07285057/"},{"id":"nct06617481","kind":"trial","name":"PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence","route":"/trials/nct06617481/"}],"biomarker":[{"id":"psma-pet-expression","kind":"biomarker","name":"PSMA expression by PET (PSMA-positive)","route":"/biomarkers/psma-pet-expression/"}]}}