FDA Accepts NDA for New Formulation of PSMA PET Imaging Agent Piflufolastat F 18 in Prostate Cancer

The FDA has accepted the new drug application (NDA) seeking the approval of a new formulation of the prostate-specific membrane antigen (PSMA) PET imaging agent piflufolastat F 18 for use in patients with prostate cancer.¹
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2026.

Piflufolastat F 18 is an injectable radioactive diagnostic agent indicated for PET of PSMA in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. The agent is also indicated for patients with suspected disease recurrence based on elevated serum prostate-specific antigen (PSA) level.

The new formulation of piflufolastat F 18 is expected to optimize the manufacturing process and increase batch size by approximately 50%, according to Lantheus, the developer of the agent. This formulation will also increase the radioactive concentration of the agent and potentially expand access for patients.

“We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation, which we expect will improve patient access due to a significant increase in the number of doses per batch,” Brian Markison, chief executive officer of Lantheus, stated in a news release. “This formulation is a natural next step in our commitment to advancing PSMA imaging. There is a growing burden of prostate cancer in the United States and a clear need for accurate and early detection. Building on [piflufolastat F 18 (Pylarify; formerly ¹⁸F-DCFPyL-PET/CT)]’s proven performance and accuracy, Lantheus is well positioned for continued leadership in prostate cancer imaging.”

Findings from the phase 3 CONDOR study (NCT03739684) revealed that piflufolastat F 18 (Pylarify) imaging generated correct localization rates (CLRs) ranging from 84.8% to 87.0% (lower bound of 95% CI, 77.8%-80.4%) across 3 central ¹⁸F-DCFPyL-PET/CT readers in patients with biochemically recurrent prostate cancer (n = 208).² Most patients (63.9%) experienced a change in intended management following piflufolastat F 18 imaging. The disease detection rates ranged between 59% and 66%.

CONDOR was a prospective, multicenter, open-label, single-arm study that enrolled patients with suspected recurrent or metastatic prostate cancer. In order to be eligible, patients needed to have rising PSA levels of at least 2 ng/mL following prostatectomy or a PSA level at least 2 ng/mL above nadir after radiation therapy, be at least 18 years old, and have negative/equivocal findings for prostate cancer on standard-of-care (SOC) imaging performed 60 days prior to imaging with piflufolastat F 18.

The CONDOR protocol specified that patients receive intravenous piflufolastat F 18 at 9 mCi (333 MBq) 1 to 2 hours prior to PET/CT. Patients voided prior to imaging, and the images were taken from mid-thigh through the skull vertex. All scans were submitted to the central imaging core laboratory for assessment, and patients with positive scans by local interpretation were scheduled for follow-up to verify the suspected lesions based on a composite standard of truth.

The primary end point was CLR, which was defined as a positive predictive value with an additional requirement of anatomic lesion colocalization between piflufolastat F 18 and a compositive SOC. Secondary end points included changes in intended management and safety.

“We have reached a key milestone and delivered on our commitment to advance prostate cancer imaging through sustainable innovation,” Paul Blanchfield, president of Lantheus, added in the news release.¹ “By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader health care system’s ability to deliver timely diagnostic imaging.”

References

1. Lantheus announces FDA acceptance of NDA for new formulation for market-leading PSMA PET imaging agent. News release. Lantheus. August 6, 2025. Accessed August 6, 2025. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-nda-new-formulation-market
2. 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. 2021;27(13):3674-3682. doi:10.1158/1078-0432.CCR-20-4573