FDA Approves Pylarify TruVu to Expand Prostate Cancer Imaging

The U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu (piflufolastat F 18), a new formulation of an established prostate cancer imaging agent designed to increase production and expand availability of prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans, according to a news release from Lantheus Holdings, Inc.

The new formulation maintains the same diagnostic performance as the original Pylarify imaging agent but allows higher radioactive concentrations, enabling manufacturers to produce larger batches of the tracer used in PET scans. This improvement is expected to potentially allow imaging centers to serve more patients and expand access to advanced diagnostic scans in regions that currently have limited availability.

PSMA PET imaging is widely used to help physicians locate prostate cancer cells throughout the body. By targeting PSMA, a protein commonly found in high levels on prostate cancer cells, these scans can detect small sites of disease that may not be visible with conventional imaging such as CT or MRI.

New imaging formulation designed to expand patient access

The FDA approval of Pylarify TruVu primarily focuses on improving manufacturing efficiency and distribution.

This change could significantly improve access to PSMA PET scans, especially for patients treated in geographic areas that previously had limited availability of these advanced imaging tests. Radiopharmaceuticals must be produced and delivered quickly because the radioactive material decays over time, which can limit how far they can be transported. Increasing batch size can help imaging providers distribute doses more efficiently to hospitals and imaging centers.

The company expects the new formulation to launch in the United States during the fourth quarter of 2026, aligning with new reimbursement codes scheduled to take effect in October of that year. These codes may provide clearer guidance for providers seeking coverage for PSMA PET imaging.

For patients, broader access to PSMA PET scans could mean earlier and more accurate detection of prostate cancer recurrence or spread, which can help guide treatment decisions.

Understanding PSMA PET imaging in prostate cancer

Pylarify is a radioactive diagnostic agent used alongside PET imaging to identify prostate cancer lesions that express PSMA. It is approved for men with prostate cancer who may have metastatic disease or who have rising prostate-specific antigen (PSA) levels suggesting recurrence after treatment.

When injected into the bloodstream, the tracer attaches to PSMA proteins found on prostate cancer cells. PET imaging can then detect where the tracer accumulates in the body, helping physicians locate cancer sites in lymph nodes, bones or soft tissues.

The original Pylarify imaging agent received FDA approval in 2021 after studies demonstrated strong diagnostic performance in detecting prostate cancer lesions.

Research supporting the agent included the phase 3 OSPREY and CONDOR trials. These studies evaluated how accurately the imaging agent could identify prostate cancer lesions. In the OSPREY trial, the imaging agent demonstrated high specificity and positive predictive value compared with conventional imaging methods such as CT or MRI.

The CONDOR study evaluated men with biochemical recurrence, meaning their PSA levels had risen after treatment. Investigators found high rates of correct lesion localization, even among patients with relatively low PSA levels.

Who may benefit from Pylarify imaging

PSMA PET imaging using Pylarify TruVu is intended for men with prostate cancer in two key situations. First, it may be used when doctors suspect the cancer has spread beyond the prostate in patients who are candidates for initial treatment. Second, it may help identify where cancer has returned in patients whose PSA levels rise after earlier therapy.

These scans can help clinicians determine the location and extent of disease, which may influence treatment planning. For example, physicians may use imaging results to guide surgery, radiation therapy or systemic treatments.

Prostate cancer remains one of the most commonly diagnosed cancers among men in the United States, with hundreds of thousands of new cases diagnosed each year. Earlier and more accurate detection tools, such as PSMA PET imaging, continue to play an increasingly important role in managing the disease.

The future of Pylarify

Although the new TruVu formulation does not change how the imaging agent works inside the body, its manufacturing improvements may help expand access to advanced imaging technologies across the country. Larger production batches could help imaging centers meet growing demand for PSMA PET scans as they become more widely used in prostate cancer care.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

References

1. “Lantheus Announces FDA Approval of PYLARIFY TruVu™ (piflufolastat F 18) Injection,” by Lantheus Holdings, Inc. News release’ March 6, 2026.

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