Novartis announced that 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). Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy.
- Breakthrough therapy designation 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 mCRPC
- Phase III VISION study demonstrated that 177Lu-PSMA-617 significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC
- The five-year survival rate for patients with metastatic prostate cancer is approximately 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 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).