FDA approves Pylarify TruVu formulation of PSMA-PET agent piflufolastat F18

The FDA has approved Pylarify TruVu (piflufolastat F 18) injection, a new formulation of the prostate-specific membrane antigen (PSMA)-PET imaging agent piflufolastat F 18 (Pylarify; ¹⁸F-DCFPyL) in prostate cancer.¹

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

Piflufolstat F 18 injection is currently indicated in the US for PET imaging of PSMA-positive lesions in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, as well as in patients with suspected recurrence based on an elevated serum prostate-specific antigen level. The recommended dose for piflufolastat F 18 is 333 MBq (9 mCi), with an acceptable range of 296 MBq to 370 MBq (8-10 mCi), administered as a bolus intravenous injection.

According to Lantheus, Pylarify TruVu is formulated to improve product stability at higher radioactive concentrations, facilitating more efficient manufacturing and distribution. These enhancements are anticipated to support larger batch production, allowing manufacturing sites with high‑energy cyclotrons to reach additional patients and expand their geographic reach. In turn, Pylarify TruVu may provide greater supply flexibility and improve operational efficiency for the network of PMFs that produce and distribute the product.¹

CONDOR and OSPREY trials evaluating piflufolastat F 18

Piflufolastat F 18 injection was approved in the US in May 2021³ based on data from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials.

In both studies, patients with prostate cancer received a single dose of piflufolastat F 18.

The OSPREY trial³ enrolled 385 patients who were divided into 2 cohorts: men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy (cohort A) and men with suspected recurrent/metastatic prostate cancer on conventional imaging (cohort B). The co–primary end points were specificity and sensitivity.

Data from cohort A showed greater specificity and positive predictive value (PPV) with piflufolastat F 18 than with conventional imaging prior to initial therapy. Investigators reported that the median specificity with piflufolastat F 18 was 97.9% (95% CI, 94.5%-99.4%) among 3 readers, compared with 65.1% with CT or MRI. Additionally, the median PPV was 86.7% with piflufolastat F 18, compared with 28.3% with conventional imaging. Sensitivity and negative predictive value did not differ significantly between the 2 arms.

The CONDOR study⁴ evaluated 208 men with a median baseline PSA level of 0.8 ng/mL (range, 0.2-98.4 ng/mL). The primary end point was correct localization rate, defined as PPV with anatomic lesion colocalization between piflufolastat F 18 and a composite standard of truth.

Findings from that trial showed high rates of correct localization and detection with piflufolastat F 18 in patients with biochemically recurrent prostate cancer, including in those with low PSA values. Overall, the correct localization rate ranged from 84.8% to 87.0%. The disease detection rate ranged from 59.1% to 65.9%.

“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. 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,” said Gina B. Carithers, president and CEO, Prostate Cancer Foundation, in the release.¹

The new formulation is expected to be commercially available in the fourth quarter of 2026 and will be launched on a rolling geographic schedule.¹

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 announces FDA acceptance of NDA for new formulation for market-leading PSMA PET imaging agent. News release. Lantheus Holdings, Inc. August 6, 2025. Accessed August 10, 2025. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-nda-new-formulation-market

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. 2021;206(1):52-61. doi:10.1097/JU.0000000000001698

4. Morris MJ, Rowe SP, Gorin MA, et al; CONDOR Study Group. 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. 2021;27(13):3674-3682. doi:10.1158/1078-0432.CCR-20-4573