Novartis Receives FDA Breakthrough Therapy Designation for Investigational 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

BASEL, Switzerland I June 16, 2021 I Novartis announced today 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 therapy1.

  • 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 mCRPC2
  • Phase III VISION study demonstrated that 177Lu-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 approximately 30%3
  • 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).

  1. U.S. Food and Drug Administration (FDA). Frequently Asked Questions: Breakthrough Therapies. Available from:
  2. 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.
  3. SEER. Cancer stat facts: prostate cancer April 2021. []

SOURCE: Novartis

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