A photo of a man looking into the camera
FDA approves new imaging agentImage by: Movember
A photo of a man looking into the camera
1 June 2021

FDA approval for imaging agent that can spot prostate cancer

Movember
2 minutes read time

Movember has welcomed the approval in the US of a new type of imaging agent that can more accurately determine whether a man’s prostate cancer has spread.

In May 2021, the US Food and Drug Administration (FDA) approved the use of Pylarify, an imaging agent that is used to carry out PET scans for men suspected to have prostate cancer spreading outside the prostate gland.

Pylarify is designed to bind to a protein that is specifically found on prostate cancer cells. When injected into a vein for a PET scan, this seek-and-target approach allows doctors to ‘see’ the cancerous tumours as small as 2-3mm anywhere in the body.

" We can't wait to see how this new technology will benefit tens of thousands of men. "

Understanding if and where a man’s cancer has spread outside of the prostate gland, will enable doctors to recommend the most effective treatment for him and it is hoped that this type of scan will transform the way prostate cancer is detected and managed in the near future.

Movember funding supported the early development of Pylarify back in 2013 for advanced prostate cancer imaging. It has since been investigated in multiple large scale clinical trials to prove the superior accuracy in detecting prostate cancer as compared to conventional imaging.

Pylarify is similar to another radiotracer 68Ga-PSMA, which was approved by the FDA in December last year.

Dr Sarah Hsaio, Director of Biomedical Research and Impact at Movember, said: “Movember is very proud to have supported the development of both of 68Ga-PSMA and Pylarify since 2013, and we can't wait to see how this new technology will benefit tens of thousands of men in providing the critical information that will be used to determine the most appropriate type of therapy for best possible outcome.”