FDA Approves Pylarify TruVu for PSMA-PET Imaging in Prostate Cancer

The FDA has approved Pylarify TruVu (piflufolastat F 18) injection for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer with suspected metastasis who can receive initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

The application for Pylarify TruVu was filed via the 505(b)(2) regulatory pathway, which allowed for review to be based on previously filed data from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials. The new formulation has the same diagnostic properties and is expected to offer comparable safety and efficacy to that of piflufolastat F 18 (Pylarify), which received regulatory approval in May 2021 to identify suspected metastasis or recurrence of prostate cancer.²

“The FDA approval of Pylarify TruVu demonstrates Lantheus’ continued commitment to advancing innovation that directly expands patient access to high-quality diagnostic tools,” Mary Anne Heino, executive chairperson and chief executive officer at Lantheus Holdings, Inc., stated in a news release.¹ “The availability of PYLARIFY TruVu addresses a key need identified by clinicians – greater access to our market-leading formulation.”

What did the OSPREY study examine?

The prospective, multicenter, multireader, open-label study enrolled patients with histologically confirmed prostate adenocarcinoma.³ The study comprised two cohorts. Those in cohort A had newly diagnosed high-risk prostate cancer (clinical stage ≥ T3a or PSA > 20 ng/mL or Gleason score of 8 or higher) who were slated to undergo radical prostatectomy with pelvic lymph node (PLN) dissection. Those in cohort B had radiological evidence of recurrent or metastatic disease on imaging and were determined to be amenable to undergo a biopsy.

In cohorts A and B, 268 and 117 patients, respectively, underwent pelvic lymph node PET/CT. In cohort A, 16 patients did not undergo radical prostatectomy/PLN dissection, and 252 underwent surgery and had PLN pathology results.; the latter group was noted to be evaluable.

Both groups were given one dose of 9 mCi (333 MBq) of the imaging agent intravenously, followed by PET/CT 1 to 2 hours after.

For cohort A of the study, investigators evaluated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in pelvic lymph nodes and the prostate gland for PSMA-targeted PET with the agent.¹

The median sensitivity was 38% (26%-51%) and the median specificity was 96% (94%-99%); the PPV was 77% (62%-92%), and the NPV was 83% (78%-88%). Results indicated that a PSMA-targeted PET scan with piflufolastat F 18 significantly improved specificity vs standard imaging; it also maintained comparable sensitivity and provided high PPV and NPV in those with high-risk prostate cancer before receipt of initial therapy.

Piflufolastat F 18 PET/CT imaging resulted in higher specificity than standard imaging, at 97.9% vs 65.1%, respectively; the former also had almost triple the PPV, at 86.7% vs 28.3%, respectively, and comparable sensitivity, at 40.3% vs 42.6%, respectively.²

What was the design of the CONDOR study?

The prospective, multicenter, open-label, single-arm, phase 3 study included men with biochemically recurrent adenocarcinoma of the prostate who received radical prostatectomy or radiotherapy.⁴ For those given radiotherapy, biochemical recurrence was defined as a PSA of at least 2 ng/mL above the post-radiation nadir value. Moreover, all patients had to have negative or equivocal findings for prostate cancer on standard imaging done 60 days before injection with the imaging agent.

The imaging agent was given at 9 mCi (333 MBq) intravenously 1 to 2 hours before PET/CT.

A total of 208 patients underwent the imaging agent/PET CT; 132 of these patients had lesion follow-up at the start of treatment, and 76 did not. Of the 132 who did have follow-up, 31 had pathology, 100 had correlative imaging, and 1 had PSA response to external beam radiotherapy.

The primary end point of the study was the correct localization rate (CLR) of the imaging agent. Secondary end points included the percentage of patients with a change in intended disease treatment plans following the imaging and safety. Exploratory end points comprised detection rates of PPVs of the imaging at the region level and the detection rate of the imaging agents as a function of baseline PSA.

Data showed that a PSMA-targeted PET scan with piflufolastat F 18 in those with biochemical recurrent disease had a CLR ranging from 85% to 87%, spanning all three readers (95% CI, 78%-80%), which met the primary end point of the research.¹

What was the safety of the piflufolastat F 18?

A total of 593 patients who had received one dose of piflufolastat F 18 were evaluated for safety, and the imaging agent was determined to be tolerable. The most common adverse reactions included headache, dysgeusia, and fatigue. One patient experienced a delayed hypersensitivity reaction; they had a history of allergic reaction.

What is the significance of the new formulation having regulatory clearance?

Pylarify TruVu is designed to strengthen product stability at higher radioactive concentrations, allowing for more efficient manufacturing and distribution, according to Lantern; this could result in increased batch sizes, and allow for manufacturing sites with high‑energy cyclotrons to reach more patients and serve broader geographic markets.

“As a community dedicated to improving the lives of people facing prostate cancer, we’ve seen firsthand how advanced PSMA PET diagnostic tools like Pylarify have truly been game changers, providing real-time, highly accurate information that can meaningfully shape treatment decisions,” Gina B. Carithers, president and chief executive officer of the Prostate Cancer Foundation, stated in the news release. “With prostate cancer incidence expected to rise in the years ahead, it’s encouraging to see companies like Lantheus putting patients first and introducing innovations that help ensure timely, precise imaging while keeping pace with growing demand. Access to accurate diagnostics, especially when metastatic or recurrent disease is suspected, can profoundly impact both quality of life and long-term outcomes for people living with prostate cancer.”

References

1. Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection. News release. Lantheus Holdings, Inc. March 6, 2026. Accessed March 6, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-approval-pylarify-truvutm-piflufolastat-f
2. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. News release. Lantheus Holdings, Inc. May 27, 2021. Accessed March 6, 2026. https://bwnews.pr/2SynyAS
3. Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPyL in prostate cancer patients (OSPREY). J Urol. Published online February 26, 2023. Accessed August 10, 2025. doi:10.1097/JU.0000000000001698
4. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: Results from the CONDOR phase III, multicenter study. Clin Cancer Res. Published online February 23, 2023. Accessed August 10, 2025. doi:10.1158/1078-0432.CCR-20-4573