The Institute of Cancer Research, London, strongly welcomes the news that 177Lu-PSMA-617, a potent radioactive medicine that searches for tumour cells to deliver a radioactive payload, has been approved by the US Food and Drug Administration (FDA) for treating some advanced prostate cancers.

The approval means people with advanced prostate cancer previously treated with at least one targeted hormone treatment – such as enzalutamide or abiraterone – alongside taxane chemotherapy will be able to access the treatment in the US. It raises hopes that the medicine, also known as Lu-PSMA, could next be approved in Europe.

Professor Johann de Bono at The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust co-led the phase III trial, VISION, which led to this approval – showing that Lu-PSMA helps men with advanced prostate cancer live longer and with a better quality of life.

Results from the VISION trial presented last year at ASCO 2021 showed that adding Lu-PSMA to standard care extended patients’ lives by an average of 4 months – to 15.3 months, compared with 11.3 for standard care alone.

Lu-PSMA works as a ‘guided missile’ – it seeks out cancer by detecting the presence of a target molecule called prostate-specific membrane antigen (PSMA), which is present on the surface of cancer cells, but not healthy ones. Once in contact, it delivers a radioactive payload to destroy them.

Researchers at the ICR were also involved in the discovery linking DNA repair defects to increased levels of PSMA – meaning that testing for genetic faults in DNA repair genes could be used as a first-stage screen to select patients for PSMA-targeted treatment.

The FDA also approved a new diagnostic agent, gallium Ga 68 gozetotide, which can be used with a PET scan to identify men with PSMA-positive advanced prostate cancer who are suitable for treatment with Lu-PSMA.

Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, co-led the VISION trial leading to the approval of Lu-PSMA. He said:

“We’re very excited that the FDA has approved this new nuclear medicine for treating men with advanced prostate cancer who have stopped responding to hormone therapy. This is a whole new class of treatment for prostate cancer.

“Lu-PSMA is an innovative and precise ‘search and destroy’ treatment capable of locating and destroying cancer cells anywhere in the body – allowing men with advanced prostate cancer to live longer and with a better quality of life.

“I hope we will next see this treatment be approved in Europe, and that it can become available for some patients on the NHS.”