FDA approves Lu-PSMA therapy for men with advanced prostate cancer
Movember strongly welcomes the landmark announcement that a radioactive medicine has been approved by the US Food and Drug Administration (FDA) for some men with advanced prostate cancer.
The approval of 177-Lutetium-PSMA-617 (Pluvicto) means that men with advanced prostate cancer who have previously treated with at least one targeted hormone treatment – such as enzalutamide or abiraterone – alongside chemotherapy will be able to access the treatment in the US.
It raises hopes that the treatment, also known as Lu-PSMA therapy, will be approved in other parts of the world, making it available to more men.
Movember has been at the forefront of funding the development of Lu-PSMA therapy through the TheraP trial which showed Lu-PSMA was six times more effective than chemotherapy. The proPSMA study showed that PSMA scanning was the most accurate means of staging prostate cancer and should be routinely used in men with high-risk disease.
" The TheraP trial showed Lu-PSMA was six times more effective than chemotherapy. "
The FDA approval was based on results from the VISION trial presented last year at ASCO 2021 which showed that Lu-PSMA therapy helps men with advanced prostate cancer live longer and with a better quality of life.
Lu-PSMA therapy works by detecting the presence of a protein called prostate-specific membrane antigen (PSMA) which exists in high numbers on the surface of the prostate cancer cells. It then destroys these prostate cancer cells, and the cancer cells around them, with the 177-Lutetium radioactive payload.
The FDA also approved a new diagnostic agent, 68-gallium (68Ga) PSMA (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.
Jane Fisher, Global Director, Cancer Research and Clinical Trials at Movember said: “We are very excited that the FDA has approved this new drug for treating men with advanced prostate cancer who have stopped responding to hormone therapy.
“We are keen to see this treatment approved in other countries and will work with governments and health systems to ensure this therapy is made available to men who will benefit from it.
“We are very grateful to our Mo community whose generous support allows us to fund transformative research which leads to the development of new therapies that allow men with advanced prostate cancer to live longer and enjoy a better quality of life.”