First PSMA PET Imaging Agent for Prostate Cancer Approved by FDA
Posted: Friday, May 28, 2021
On May 27, Lantheus Holdings announced that the U.S. Food and Drug Administration (FDA) has approved piflufolastat F 18 injection (Pylarify) to identify suspected metastasis or recurrence of prostate cancer. This is the first commercially available F 18–labeled prostate-specific membrane antigen (PSMA)-targeted positron-emission tomography (PET) imaging agent.
The approval is based on data from two company-sponsored studies: OSPREY and CONDOR. A combined 593 patients from these studies, who had various stages of prostate cancer, were exposed to a single dose of piflufolastat F 18. Results from Cohort A of the OSPREY trial demonstrated improvement in specificity and positive predictive value of this imaging agent over conventional imaging in men at risk for metastatic prostate cancer prior to intitial therapy. In the CONDOR trial, which focused on men with biochemical recurrence of prostate cancer, piflufolastat F 18 demonstrated high correct localization and detection rates, including in patients with low prostate-specific antigen values (median, 0.8 ng/mL).
The investigators of the studies reported that the imaging agent was well tolerated. Adverse reactions (headache, dysgeusia, and fatigue) were reported in up to 2% of patients within these studies. In addition, a delayed hypersensitivity reaction was reported in one patient with a history of allergic reaction.
According to lead investigator of the CONDOR trial, Michael J. Morris, MD, Prostate Cancer Section Head, Genitourinary Medical Oncology, Memorial Sloan Kettering Cancer Center, this tool may help “clinicians develop treatment plans based on a much more accurate understanding of a patient’s distribution of disease.”
