Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177 Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy1.

Breakthrough therapy designation granted based on positive data from the pivotal, Phase III VISION study evaluating 177 Lu-PSMA-617, a targeted radioligand therapy, plus standard of care (SOC), compared to SOC alone, in patients with progressive PSMA-positive mCRPC2.

Phase III VISION study demonstrated that 177 Lu-PSMA-617 significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC2
The five-year survival rate for patients with metastatic prostate cancer is approximate 30%.

Novartis is a global leader in radioligand therapy, uniquely positioned with broad commercial experience, established manufacturing and supply chain capabilities, and extensive development expertise

Two additional studies with 177 Lu-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).