FDA Approves New Formulation of the PSMA PET Agent Pylarify

The Food and Drug Administration (FDA) has approved Pylarify TruVu™, a new formulation of the prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging agent Pylarify (piflufolastat F 18).

Pylarify TruVu is indicated for PSMA PET imaging for men with suspected recurrence of prostate cancer (PCa) due to elevated prostate-specific antigen (PSA) levels or those with suspected metastasis of PCa who are candidates for initial definitive therapy, according to Lantheus, the developer of Pylarify TruVu.

Noting that Pylarify TruVu was designed to enhance the stability of piflufolastat F 18 at higher radioactive concentrations, Lantheus said this initiative will support greater manufacturing efficiencies and increased batch sizes of the agent. The company said this may facilitate improved access to Pylarify TruVu for men with PCa.

“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, the executive chairperson and CEO of Lantheus.

“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,” posited Gina B. Carithers, the president and CEO of the Prostate Cancer Foundation.