Flotufolastat F-18
Flotufolastat is a third PSMA PET tracer, with a radiohybrid chemistry designed to be reused for therapy.
Overview
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.
- Detector ring
- PSMA ligand
- 511 keV photon pair
1.Flotufolastat F-18 slips into a pocket on PSMA.
- PSMA PET (Ga-68 PSMA-11, F-18 piflufolastat, F-18 flotufolastat) · At least one PSMA-positive lesion and no dominant PSMA-negative lesion (VISION criteria) for lutetium-177 PSMA-617
- Medicare
- Part B (clinician-administered)
Diagnostic radiopharmaceutical billed with the PET/CT scan under Part B; same coverage pathway as other PSMA PET agents.
- Commercial insurance
- covered with prior authorisation
Commercial plans cover PSMA PET for staging and recurrence with prior authorisation of the imaging procedure.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Diagnostic non-laboratory tests (imaging). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation yet, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: flotufolastat F-18. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | PSMA PET in prostate cancer |
Trials
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Latest papers
topQuery for this drug: (TITLE:"Flotufolastat F-18" OR ABSTRACT:"Flotufolastat F-18" OR TITLE:"Posluma" OR ABSTRACT:"Posluma" OR TITLE:"18F-rhPSMA-7.3" OR ABSTRACT:"18F-rhPSMA-7.3") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Flotufolastat F-18, not a curated reading list.
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