The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of the prostate-specific membrane antigen (PSMA) PET imaging agent piflufolastat F 18, designed to improve access for prostate cancer patients.
The agency set a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2026, for its decision on the application, submitted by developer Lantheus.
Piflufolastat F 18 (marketed as Pylarify) is an injectable radioactive diagnostic agent approved for PET imaging of PSMA in prostate cancer patients.
It is indicated for two key groups: those with suspected metastasis being considered for initial definitive therapy, and those with suspected disease recurrence due to elevated serum prostate-specific antigen (PSA) levels.
The new formulation aims to address growing demand by optimizing manufacturing processes. According to Lantheus, it will increase batch size by approximately 50% and boost radioactive concentration, potentially expanding the number of available doses per batch.
This advancement aligns with the urgent need for accurate, early detection tools amid rising prostate cancer burdens in the U.S.
“We are pleased the FDA accepted [the] 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, in a news release. He emphasized that the update builds on the agent’s proven performance, reinforcing Lantheus’ leadership in prostate cancer imaging.
Efficacy data supporting piflufolastat F 18 comes from the phase 3 CONDOR study (NCT03739684), which enrolled 208 patients with biochemically recurrent prostate cancer.
Results showed correct localization rates (CLRs) of 84.8% to 87.0% across three central readers, with most patients (63.9%) experiencing changes in intended management after imaging. Disease detection rates ranged from 59% to 66%, highlighting the agent’s clinical value in guiding treatment decisions.
Paul Blanchfield, president of Lantheus, noted the NDA acceptance as a key milestone in the company’s commitment to “sustainable innovation” in prostate cancer imaging.
“By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader health care system’s ability to deliver timely diagnostic imaging,” he stated.
READ MORE
