F-18 (Pyflufolastate)

2021: Entering the PET Imaging Agent Market for Prostate Cancer Diagnosis

In early July 2021, a new detection agent appeared on the market, PATvisualization prostate cancer providing a more effective diagnosis for assessing metastases and spreading cancer cells. The F-18 injection pyflufolastate was the first agent containing a fluorinated prostate-specific membrane antigen (PSMA) as well as the first commercially available PSMA agent for PET imaging.

This agent has been approved by regulatory authorities for PET imaging of PSMA-positive lesions in men with prostate cancer and suspected cancer metastasis who are candidates for radical therapy, or with suspected cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. blood

First-of-its-kind PET imaging agent for prostate cancer diagnosis released

We believe that the emergence of a new PET imaging agent in the market will seriously change the situation for all prostate cancer patients, said Jamie Bearse, chief executive officer of patient advocacy group ZERO - The End of Prostate Cancer. - The presence of a diagnostic tool that allows doctors to detect metastatic or recurrent prostate cancer in early stages with lesions in any part of the body is a significant step forward in the therapy of this disease, which can have a huge impact on the lives of patients.

The agent, originally called 18F-DCFPyL, was developed by Martin Pomper, MD, PhD, and director of the Division of Nuclear Medicine and Molecular Imaging at the Johns Hopkins University School of Medicine. An application for a new drug was submitted in September 2020, and already in December, US regulators considered it as a breakthrough drug as a priority. Evidence supporting the efficacy of the agent was obtained from two reference multicenter studies, the CONDOR study and the OSPREY study.^[1]

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