- Priority Review is based on positive data from the pivotal, Phase III VISION study showing 177Lu-PSMA-617 plus standard of care (SOC), significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC compared to SOC alone2
- Two additional studies with 177Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating clinical utility in the pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition)3,4
The FDA previously granted Breakthrough Therapy designation for 177Lu-PSMA-617 for the treatment of mCRPC. Data from the VISION study were published in The New England Journal of Medicine (NEJM).2 Novartis is also evaluating additional opportunities to investigate 177Lu-PSMA-617 in earlier stages of prostate cancer.
- U.S. Food and Drug Administration (FDA). Priority Review. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated...(link is external).
- Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. New England Journal of Medicine 2021. doi: 10.1056/NEJMoa2107322
- Novartis Pharmaceuticals. 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PSMAfore). U.S. National Library of Medicine: Clinical Trials. 2020; NCT04689828
- Novartis Pharmaceuticals. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). U.S. National Library of Medicine: Clinical Trials. 2021; NCT04720157
Source: "FDA Grants Priority Review For Investigational Targeted Radioligand Therapy 177Lu-PSMA-617 For Patients With Metastatic Castration-Resistant Prostate Cancer (Mcrpc) | Novartis". 2021. Novartis.
The Clinical Implications of The VISION Trial, PSMA-Targeted Radiotherapy in Metastatic Prostate Cancer - Michael Morris
ESMO 2021: Health-Related Quality of Life, Pain and Safety Outcomes in the Phase 3 VISION Study of 177Lu-PSMA-617 in Patients with mCRPC