A father and son smiling at each other mid-conversation
New imaging agent achieves FDA approvalImage by: Movember
A father and son smiling at each other mid-conversation
28 January 2021

New drug for PSMA-PET scans wins US approval

2 minutes read time

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

In December, the Food and Drug Administration (FDA) granted approval to the University of California, Los Angeles and the University of California, San Francisco of 68Ga-PSMA-11, a drug which is used to carry out PSMA-PET scans for men with prostate cancer.

According to recent Movember-funded studies, PSMA-PET scans have been proven to be both more accurate and cheaper than conventional CT and bone scans in detecting prostate cancer.

During a PSMA-PET scan, the 68Ga-PSMA-11 is injected into a vein and finds its way to prostate cancer cells and binds with them. This allows doctors to see cancerous cells as small as 3mm using a PET scanner in combination with CT or MRI scans which take detailed images of the whole body.

This technology has great potential to transform the way prostate cancer is detected and managed.

Dr Sarah Hsiao, Director of Biomedical Research and Impact at Movember said: "There is now solid evidence that PSMA-PET scans are the gold standard to inform treatment decisions for men with suspected prostate cancer metastasis.

"The FDA approval is an important milestone because it paves the way for other institutions in the US to apply for approval of 68Ga-PSMA-11 on the back of this decision.

“It brings us a step closer to our goal of having PSMA-PET scans adopted into clinical practice as soon as possible for this group of men.”

Results of the Movember-funded proPSMA study, published in The Lancet medical journal in March 2020, showed that PSMA-PET/CT scans were more accurate than current standard scanning techniques (CT and bone scans) in detecting disease that has spread outside of the prostate.

The proPSMA study was funded by Movember via a partnership with the Prostate Cancer Foundation of Australia. The trial was supported and co-badged by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).