New formulation of popular PSMA imaging agent could up availability by 50%
The U.S. Food and Drug Administration has accepted a New Drug Application for a new formulation of a commercially available PSMA imaging agent.
Lantheus’ Piflufolastat F18, distributed under the brand name Pylarify, is a diagnostic PET imaging agent that targets PSMA-positive lesions in men with suspected prostate cancer metastases or recurrence. It was approved by the FDA in May of 2021.
The New Drug Application was submitted to the FDA for the purpose of approving a reformulation of the agent. This would enable Lantheus to increase batch sizes by approximately 50%; it would also increase the agent’s radioactive concentration.
Brian Markison, chief executive officer of Lantheus, said the move will hopefully expand access to the agent to more patients.
“We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation, which we expect will improve patient access due to a significant increase in the number of doses per batch,” Markison said in a news release. “This formulation is a natural next step in our commitment to advancing PSMA imaging. There is a growing burden of prostate cancer in the United States and a clear need for accurate and early detection. Building on [piflufolastat F 18 (Pylarify; formerly 18F-DCFPyL-PET/CT)]’s proven performance and accuracy, Lantheus is well positioned for continued leadership in prostate cancer imaging.”
Paul Blanchfield, president of Lantheus, added the reformulation will “support the broader health care system’s ability to deliver timely diagnostic imaging.”
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2026.
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.