FDA clears new formulation of Lantheus' PSMA imaging agent
The U.S. Food and Drug Administration just cleared a new formulation of a popular PSMA-targeting radiopharmeceutical.
On March 6, Lantheus announced the clearance of its Pylarify TruVu (piflufolastat F 18) injection, which is a reformulation of Pylarify. The reformulation also is indicated for PET imaging of PSMA (prostate-specific membrane antigen)-positive lesions in men with prostate cancer and suspected metastasis who are candidates for initial definitive therapy, or those in whom recurrence is suspected due to elevated PSA levels.
The hope is that the reformulation will increase access to the imaging agent, as it has been redesigned to enhance its stability at higher radioactive concentrations. This will open the door for increased batch sizes, which will enable manufacturing sites with high-energy cyclotrons to be able to distribute more doses to more patients.
“As we continue to innovate and expand our portfolio, ensuring a reliable and uninterrupted supply for our customers remains our top priority,” Senior Vice President, Manufacturing and Technical Operations for Lantheus, Dorothy Barr, said in a statement. “The PYLARIFY TruVu formulation is designed to enhance manufacturing efficiency, strengthen supply chain dependability and ultimately improve the healthcare system’s ability to deliver timely, accurate imaging for people with prostate cancer.”
Lantheus expects the reformulated agent to be commercially available by the fourth quarter of 2026. It will be introduced on a rolling geographic basis in order to allow clinicians to make the transition from Pylarify to the reformulation without disrupting workflows.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.