FDA Approves Piflufolastat F 18 Injection for the Detection of PSMA-Positivity Among Patients With Prostate Cancer
Key Clinical Summary:
- Design/Regulatory Context: Piflufolastat F 18 is a new formulation of fluorine-18 PSMA PET imaging and is indicated for PSMA-positive lesion detection among patients with suspected metastatic or recurrent prostate cancer.
- Key Findings: In clinical trials, PSMA PET imaging with piflufolastat F 18 demonstrated high specificity and improved positive predictive value compared with standard imaging modalities. Safety findings were consistent with prior experience, with low rates of mild adverse events.
- Clinical Relevance: The new formulation is designed to enhance manufacturing efficiency and distribution capacity while maintaining diagnostic performance. Broader access to PSMA PET imaging may support timely and accurate staging and recurrence detection in prostate cancer.
On March 6, 2026, the US Food and Drug Administration (FDA) approved piflufolastat F 18 (PYLARIFY TruVuTM), a new formulation of the fluorine-18 prostate-specific membrane antigen (PSMA) PET imaging agent, for detection of PSMA-positive lesions among patients with prostate cancer.
This approval was supported by efficacy and safety data from the OSPREY and CONDOR trials. In cohort A of the phase 2/3 OSPREY trial, 252 patients with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy received piflufolastat F 18 PET/CT. Median sensitivity was 38%, and median specificity was 96%. Median positive predictive value (PPV) was 77%, and median negative predictive value (NPV) was 83%. Compared with standard imaging and confirmed by histopathology, piflufolastat F 18 PET/CT demonstrated higher specificity (97.9% vs 65.1%), nearly threefold higher PPV (86.7% vs 28.3%), and similar sensitivity (40.3% vs 42.6%).
In the phase 3 CONDOR trial, 208 patients with suspected recurrent or metastatic prostate cancer and negative or equivocal standard imaging received piflufolastat F 18 PET/CT. PSMA-targeted PET imaging achieved a correct localization rate of 85% to 87% across 3 independent readers.
Across clinical studies, 593 patients received a single dose of piflufolastat F 18. The most frequently reported adverse events occurring in ≤ 2% of patients were headache, dysgeusia, and fatigue. A delayed hypersensitivity reaction occurred in 1 patient with a history of allergic reactions. Piflufolastat F 18 is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum PSA levels.
Important safety considerations include the risk of image misinterpretation, hypersensitivity reactions, and radiation exposure. A negative image does not rule out prostate cancer, and a positive image does not confirm prostate cancer without clinical correlation. Piflufolastat F 18 uptake is not specific to prostate cancer and may occur in other malignancies or benign processes.
Source:
Lantheus. Lantheus announces FDA approval of PYLARIFY TruVu™ (piflufolastat F 18) injection. Accessed March 11, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f
