Lantheus Holdings announced that the FDA has accepted a New Drug Application for an enhanced formulation of its F 18 PSMA imaging agent piflufolastat F 18, filed by its affiliate Aphelion. The FDA has set a PDUFA action date goal of March 6, 2026 for the regulatory review.
The new formulation is designed to optimize manufacturing processes and increase batch size by approximately 50%, allowing Lantheus to serve significantly more patients while maintaining the same diagnostic standards that have made PYLARIFY the market-leading PSMA PET imaging agent. The enhanced formulation increases the radioactive concentration of the agent and has the potential to expand patient access in new geographic locations.
Clinical Performance and Market Position
The enhanced formulation builds on the proven clinical performance of PYLARIFY, which has demonstrated an 86% median true-positive rate based on three independent readers in a study of patients with recurrent prostate cancer based on rising PSA after therapy. PYLARIFY is currently the number one ordered PSMA PET imaging agent in the United States, backed by real-world experience including over 500,000 scans across 48 states, Puerto Rico and Washington, D.C.
"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," said Brian Markison, CEO of Lantheus. "This formulation is a natural next step in our commitment to advancing PSMA imaging."
Manufacturing and Supply Chain Improvements
The new formulation optimizes the manufacturing process by increasing the radioactive concentration of the imaging agent, which directly translates to enhanced production efficiency. Paul Blanchfield, President of Lantheus, emphasized that "by enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader healthcare system's ability to deliver timely diagnostic imaging."
Clinical Context and Disease Burden
Prostate cancer represents a significant clinical challenge in the United States, where it is the second most frequently diagnosed cancer and fifth-leading cause of cancer-related deaths among men globally. For 2025, estimates suggest nearly 315,000 new cases and more than 35,000 deaths. Projections indicate a significant increase in prostate cancer incidence, with annual cases expected to nearly double to 2.9 million by 2040, largely attributed to aging populations and increased life expectancy.
PSMA PET Imaging Technology
PYLARIFY (piflufolastat F 18) injection is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. The agent combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for diagnostic performance.
The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. The agent is indicated for positron emission tomography of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, and with suspected recurrence based on elevated serum prostate-specific antigen levels.
Safety Profile
Clinical studies with PYLARIFY have shown that the most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at a rate of ≤2%. A delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions. The agent carries standard warnings for diagnostic radiopharmaceuticals, including risks of image misinterpretation, hypersensitivity reactions, and radiation exposure.
