FDA Brief: Radioligand Therapy Receives Breakthrough Therapy Designation in Prostate Cancer
Posted: Thursday, June 24, 2021
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to the investigational radioligand therapy lutetium-177–PSMA-617 (LuPSMA) to treat metastatic castration-resistant prostate cancer. Two additional studies with LuPSMA in earlier lines of treatment for metastatic prostate cancer are ongoing. They will be investigating the potential clinical utility in pretaxane setting for metastatic castration-resistant prostate cancer and in the metastatic hormone-sensitive setting.
The FDA’s decision was based on the phase III VISION study evaluating LuPSMA plus the standard of care, compared with the standard of care alone in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer. The trial results showed that the radioligand therapy significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive metastatic castration-resistant prostate cancer. The 5-year survival rate for patients with metastatic prostate cancer has been approximately 30%.
