FDA Approves Piflufolastat F 18 PSMA PET Imaging Agent for Prostate Cancer


The FDA has approved piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.



The FDA has approved piflufolastat F 18 (Pylarify) injection, a prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent, to identify suspected metastasis or recurrence of prostate cancer.

The product will be made immediately available to parts of the mid-Atlantic and southern regions, according to Lantheus Holdings, Inc. Moreover, availability is expected to undergo rapid expansion over the next 6 months, with broad availability across the United States expected by the end of the year.

“The FDA approval of [piflufolastat F 18] is a significant milestone for Lantheus and the prostate cancer community in the United States. We believe [piflufolastat F 18] represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors, along with patients and their families, can make more informed treatment decisions,” Mary Anne Heino, president and chief executive officer of Lantheus, stated in a press release. “I would like to thank the patients who participated in our clinical trials, the study investigators and our employees, whose efforts made this achievement possible.”

The product was developed to target PSMA, a protein that is overexpressed on the surface of upward of 90% of primary and metastatic prostate cancer cells. The agent adheres to the target, enabling the reader of the PET scan to identify and locate the disease. Cyclotron production of F 18 offers high-batch capacity and high image resolution, and the agent's 110-minute half-life allows for broad geographic distribution.

The regulatory decision was supported by data from 2 pivotal studies: OSPREY and CONDOR; these trials were designed to establish the safety and diagnostic performance of the imaging agent across the prostate cancer disease continuum.

Results from cohort A of the OSPREY study indicated improvement in specificity and positive predictive value (PPV) of the product PET imaging vs conventional imaging in patients at risk for metastatic prostate cancer before initial therapy. In the CONDOR study, investigators enrolled patients with biochemical recurrent prostate cancer. In this patient population and non-informative baseline imaging, the agent was found to have high correct localization and detection rates, including in those with low PSA values, defined as a median PSA 0.8 ng/mL.

In the clinical trials, the product was determined to be well tolerated. In OSPREY and CONDOR, 593 patients with various states of prostate cancer were exposed to a single dose of the agent. Adverse effects such as headache, dysgeusia and fatigue were reported in 2% or less of patients within the studies. Moreover, a delayed hypersensitivity reaction was reported in one patient (0.2%) who had a history of allergic reaction.


Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. News release. Lantheus Holdings, Inc. May 27, 2021. Accessed May 27, 2021. https://bwnews.pr/2SynyAS

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