Lantheus Holdings, Inc. (NASDAQ: LNTH), a leader in radiopharmaceuticals, revealed on August 6, 2025, that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) submitted by its affiliate, Aphelion, for an advanced formulation of piflufolastat F 18, the active ingredient in its flagship PSMA-targeted PET imaging agent, PYLARIFY. The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2026, paving the way for potential approval that could significantly expand access to this diagnostic tool for prostate cancer patients. This development builds upon PYLARIFY’s established success, which has revolutionized prostate cancer imaging with superior diagnostic performance, including an 86% median true-positive rate for detecting recurrent disease in patients with rising PSA levels post-therapy, as demonstrated in clinical studies with independent readers.
The new formulation enhances manufacturing by increasing the radioactive concentration, enabling batch sizes to grow by about 50%. This improvement is expected to allow Lantheus to produce more doses per production run, thereby serving a larger patient population, streamlining operations, and extending availability to underserved geographic areas. Brian Markison, CEO of Lantheus, highlighted the formulation’s potential to address the growing prostate cancer burden in the U.S., where it ranks as the second most diagnosed cancer in men, with nearly 315,000 new cases and over 35,000 deaths projected for 2025. Globally, incidence is forecasted to surge to 2.9 million cases annually by 2040, driven by aging demographics and varying healthcare access. Paul Blanchfield, President of Lantheus, underscored the milestone as a commitment to innovation in PSMA imaging, supporting timely diagnostics amid these trends.
PYLARIFY, also known as 18F-DCFPyL, is a fluorinated small-molecule agent that targets prostate-specific membrane antigen (PSMA) for PET imaging, aiding in visualizing metastases in lymph nodes, bone, and soft tissues for men with suspected metastasis or recurrence based on elevated PSA. Administered intravenously at 333 MBq (9 mCi), it has been utilized in over 500,000 scans across 48 states, Puerto Rico, and Washington, D.C., establishing it as the top-ordered PSMA PET agent in the U.S. Key safety considerations include risks of image misinterpretation, hypersensitivity reactions, radiation exposure, and adverse effects like headaches, dysgeusia, and fatigue (≤2% incidence). Interactions with androgen deprivation therapies may alter uptake, necessitating clinical correlation.
This NDA acceptance aligns with Lantheus’ mission to “Find, Fight and Follow” disease, positioning the company for sustained leadership in radiopharmaceuticals. Forward-looking statements caution that approval and commercialization depend on factors like regulatory outcomes and technology transfers, with risks outlined in SEC filings. If approved, the formulation promises to enhance supply resilience and patient outcomes in the fight against prostate cancer.
