Piflufolastat F-18 / Pylarify TruVu
Piflufolastat F-18 (Pylarify) is the leading PSMA PET tracer for prostate cancer, with a new formulation approved in March 2026.
Overview
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
18F-labelled PSMA-binding urea. Connects to PSMA.
1.18F-labelled small molecule binds the PSMA active site
- 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: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- 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; separately paid in the hospital outpatient system since 2025. Coverage of the scan itself is set by the local Medicare Administrative Contractor.
- 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
- US product; UK PSMA PET uses gallium-68 PSMA-11 or F-18 PSMA-1007 supplied by NHS radiopharmacies.
- NHS England
- Not routinely funded
Sources: NICE search: piflufolastat F-18. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- 26 May 2021ApprovalUS
PSMA PET imaging in prostate cancer: first 18F PSMA agent source
- 9 Mar 2026ApprovalUS
Pylarify TruVu formulation source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | PSMA PET imaging in prostate cancer |
| US | 2026 | Pylarify TruVu formulation |
| EU | 2023 | EU brand Pylclari (Curium) |
| Adverse event |
|---|
| Headache |
| Dysgeusia |
| Fatigue |
Rare; diagnostic dose. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare pass-through/payment for PSMA PET; broad commercial coverage for staging and biochemical recurrence | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
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Latest papers
topQuery for this drug: (TITLE:"Piflufolastat F-18 / Pylarify TruVu" OR ABSTRACT:"Piflufolastat F-18 / Pylarify TruVu" OR TITLE:"Pylarify" OR ABSTRACT:"Pylarify" OR TITLE:"18F-DCFPyL" OR ABSTRACT:"18F-DCFPyL") 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 Piflufolastat F-18 / Pylarify TruVu, not a curated reading list.
Similar pages
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