FDA grants breakthrough designation to radioligand therapy for advanced prostate cancer
The FDA granted breakthrough therapy designation to 177Lu-PSMA-617 for treatment of metastatic castration-resistant prostate cancer, according to the agent’s manufacturer.
177Lu-PSMA-617 (Novartis) is an investigational radioligand therapy.
Data derived from Morris MJ, et al. Abstract LBA4. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.
During radioligand therapy, a targeting compound that binds to markers expressed by tumors is combined with a radioactive isotope. This approach allows for targeted delivery of radiation to the tumor and surrounding microenvironment while limiting damage to nearby healthy tissue.
The randomized phase 3 VISION study evaluated the addition of 177Lu-PSMA-617 to standard of care for men with prostate-specific membrane antigen (PSMA)-positive, metastatic castration-resistant prostate cancer.
As Healio previously reported, results presented during the plenary session of this year’s virtual ASCO Annual Meeting showed men assigned 177Lu-PSMA-617 achieved significantly longer OS and radiographic PFS.
Two additional ongoing studies are evaluating 177Lu-PSMA-617 in earlier lines of treatment for men with metastatic prostate cancer, according to a Novartis-issued press release.
References:
- Morris MJ, et al. Abstract LBA4. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.
- Novartis. Novartis receives FDA breakthrough therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC). Available at: https://www.novartis.com/news/novartis-receives-fda-breakthrough-therapy-designation-investigational-177lu-psma-617-patients-metastatic-castration-resistant-prostate-cancer-mcrpc. Accessed June 17, 2021.