FDA Approves New Formulation of Pylarify for Prostate Cancer PET Imaging

The Food and Drug Administration has approved a new formulation of piflufolastat F 18 injection, marketed as Pylarify TruVu, for leverage in positron emission tomography (PET) imaging of prostate cancer. This approval, announced by Lantheus Holdings on March 6, 2026, builds upon the initial FDA approval of Pylarify in 2021 and aims to improve access to this important diagnostic tool for men with suspected prostate cancer metastasis or recurrence.

Pylarify TruVu is designed for PET imaging to identify prostate-specific membrane antigen (PSMA) positive lesions. PSMA is a protein often found in higher concentrations on prostate cancer cells than on healthy cells, making it a useful target for imaging. The agent is indicated for men who are candidates for initial definitive therapy or who are suspected of having recurrent prostate cancer based on rising prostate-specific antigen (PSA) levels. Recent research has also highlighted the presence of microplastics within prostate cancer tumors, adding another layer to the understanding of this complex disease.

Expanding Access Through Enhanced Stability

The original Pylarify formulation received FDA approval in May 2021, offering a significant advancement in prostate cancer imaging. As previously reported by Healio, this initial approval allowed for the identification of suspected metastasis or recurrence. Pylarify TruVu was submitted for approval through the 505(b)(2) regulatory pathway, which allows the FDA to consider data from previous studies. According to Lantheus Holdings, the new formulation offers improved product stability at higher radioactive concentrations. This enhanced stability is expected to increase batch sizes and enable manufacturing sites equipped with high-energy cyclotrons to produce the agent, potentially reaching a larger patient population.

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

Understanding PET Imaging and PSMA

Positron emission tomography (PET) is an imaging technique that uses a radioactive tracer to visualize metabolic activity within the body. In the case of Pylarify TruVu, the tracer binds to PSMA, allowing clinicians to identify areas where the protein is highly expressed, which often indicates the presence of prostate cancer cells. This can be particularly useful in determining the extent of the disease and whether it has spread (metastasized) to other parts of the body.

The use of PSMA-targeted PET imaging has become increasingly common in recent years, offering improved accuracy compared to traditional imaging methods. However, the availability of these agents has been limited by manufacturing challenges. Pylarify TruVu aims to address these challenges by providing a more stable formulation that can be produced in larger quantities.

Clinical Trial Data and Considerations

The FDA’s approval of Pylarify TruVu was based on data from two pivotal studies. Whereas specific details of these studies haven’t been widely publicized outside of the press release, the 505(b)(2) pathway suggests the FDA reviewed existing data supporting the safety and efficacy of the original Pylarify formulation, alongside data demonstrating the improved stability of the new formulation. It’s important to note that the new formulation is expected to have similar safety and efficacy to the original agent.

As with any medical imaging procedure, You’ll see potential risks associated with PET scans, including exposure to radiation. However, the radiation dose from Pylarify TruVu is considered to be relatively low. Patients should discuss the potential risks and benefits of PET imaging with their healthcare provider.

What This Means for Patients

The approval of Pylarify TruVu is positive news for men with prostate cancer, as it has the potential to improve access to a valuable diagnostic tool. More widespread availability of the agent could lead to earlier and more accurate detection of metastasis, which can inform treatment decisions and potentially improve outcomes. However, it’s crucial to remember that PET imaging is just one piece of the puzzle when it comes to managing prostate cancer. Treatment decisions should be made in consultation with a qualified oncologist, taking into account a variety of factors, including the stage of the cancer, the patient’s overall health, and their preferences.

Availability and Future Outlook

Lantheus Holdings anticipates that Pylarify TruVu will be commercially available in the fourth quarter of 2026. The company is working to ensure a smooth transition to the new formulation and to make it accessible to as many patients as possible. Further research may explore the potential of Pylarify TruVu in other applications, such as monitoring response to treatment or identifying patients who are most likely to benefit from specific therapies. Ongoing surveillance and data collection will be essential to monitor the long-term impact of this new formulation on patient care.

For more information about prostate cancer and PSMA PET imaging, patients can consult with their healthcare provider or visit the websites of organizations such as the American Cancer Society and the American Urological Association.