FDA Approves New Formulation of PSMA Imaging Agent for Prostate Cancer

The Food and Drug Administration (FDA) has approved Pylarify TruVu, a new formulation of piflufolastat F 18 injection, for use in positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The original piflufolastat F 18 injection (Pylarify) received FDA approval in May 2021 for identifying suspected metastasis or recurrence of prostate cancer. Lantheus Holdings announced the approval of Pylarify TruVu on March 6, 2026.

Indications and Regulatory Pathway

Pylarify TruVu is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer who are candidates for initial definitive therapy or are suspected of recurrence based on elevated prostate-specific antigen (PSA) levels. The agent was submitted for FDA approval through the 505(b)(2) regulatory pathway, which allows the agency to review data from previously conducted studies.

Enhanced Product Stability and Access

According to Lantheus Holdings, Pylarify TruVu is designed to enhance product stability at higher radioactive concentrations. This is expected to increase batch sizes and enable manufacturing sites with high-energy cyclotrons to produce the agent, potentially improving access for more patients.

Statements from Lantheus Holdings

“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 demand identified by clinicians — greater access to our market-leading formulation.”

Availability

Pylarify TruVu is expected to be commercially available in the fourth quarter of 2026.