Novartis Receives FDA Breakthrough Therapy Designation for 177Lu-PSMA-617 in mCRPC Patients

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).

1. Morris M, et al. Phase 3 study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). Oral presentation at: ASCO Annual Meeting; June 6, 2021.
2. Cancer stat facts: prostate cancer April 2021. Available at: https://seer.cancer.gov/statfacts/html/prost.html.