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.
Tradename Pylarify.
Helps 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.
It targets 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, PSMA.
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.
The OSPREY study indicated improvement in specificity and positive predictive value (PPV) of PET imaging vs conventional imaging in patients at risk for metastatic prostate cancer before initial therapy.
In the CONDOR study 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.
Adverse effects such as headache, dysgeusia and fatigue were reported in 2% or less of patients.
Positive PSMA imaging is an indicator for a higher response with the use of Lu-PSMA-617.
Flotufolastat fluorine-18 (Posluma), approved radiopharmaceutical for use with positron-emission tomography (PET) in prostate cancer.