The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for an improved formulation of piflufolastat F 18 (marketed as Pylarify), a cutting-edge positron emission tomography (PET) imaging agent used to detect prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients.
This acceptance marks a significant advancement in prostate cancer diagnostics, aiming to broaden patient access and improve imaging efficiency. The FDA has set a target action date for this application of March 6, 2026, under the Prescription Drug User Fee Act.
The updated formulation is designed to optimize the manufacturing process by increasing batch sizes by approximately 50%, enabling the drug’s sponsor, Lantheus Holdings, to produce more doses per batch. This enhancement is expected to facilitate expanded geographic distribution and better serve the growing population of men requiring accurate and timely prostate cancer detection.
Brian Markison, CEO of Lantheus, stated, “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. This formulation represents a natural next step in advancing PSMA imaging, addressing the increasing burden of prostate cancer in the United States.”
The original piflufolastat F 18 agent has demonstrated high diagnostic accuracy, with clinical studies reporting a median true-positive detection rate of 86% in men with recurrent prostate cancer exhibiting rising prostate-specific antigen (PSA) levels. It targets PSMA, a protein widely expressed on prostate cancer cells, enabling precise localization of cancerous lesions and aiding clinical decisions regarding metastasis and recurrence.
Prostate cancer remains the second most commonly diagnosed cancer among men in the U.S., with an estimated 315,000 new cases and over 35,000 related deaths projected in 2025. The new formulation aims to address diagnostic challenges by enhancing the availability and efficiency of PSMA PET imaging services across broader regions.
Manufacturing improvements include increased radioactive concentration and batch size for the radiopharmaceutical, which is notable given the short half-life of the F 18 isotope used. Producing more doses per synthesis batch supports streamlined distribution and reduces delays in patient access, particularly important for remote or underserved areas.
Clinicians are reminded that piflufolastat F 18 imaging requires careful interpretation, as uptake may occur in non-prostatic malignancies or benign conditions. Safety precautions such as monitoring for rare hypersensitivity reactions and managing radiation exposure for patients and healthcare workers remain essential. Common adverse effects reported include headaches, altered taste sensation, and fatigue, each occurring in fewer than 2% of patients.
This milestone FDA acceptance anticipates potential approval that could significantly enhance clinical prostate cancer imaging. The March 6, 2026, PDUFA date is highly anticipated by the oncology and radiology communities as it promises to improve early and accurate diagnosis for men affected by prostate cancer.
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