The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) from Novartis.
According to the company, breakthrough therapy designation was granted based on positive data from the pivotal, Phase III VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus standard of care (SOC), compared to SOC alone, in patients with progressive PSMA-positive mCRPC1. The Phase III VISION study demonstrated that 177Lu-PSMA-617 significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC1. The five-year survival rate for patients with metastatic prostate cancer is approximately 30%2.
Two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition).
Novartis Gets FDA Breakthrough Therapy Designation for 177Lu-PSMA-617 in mCRPC Patients. Appl Radiol.