FDA grants priority review to targeted radioligand therapy for advanced prostate cancer
The FDA granted priority review to 177Lu-PSMA-617 for treatment of certain men with advanced prostate cancer.
The designation applies to use of 177Lu-PSMA-617 (Novartis), an investigational targeted radioligand therapy, by men with metastatic castration-resistant disease who received androgen receptor pathway inhibition and taxane-based chemotherapy.
The FDA is expected to make a decision on approval in the first half of 2022.
The agency based the priority review designation on results of the randomized phase 3 VISION study.
As Healio previously reported, results presented during the plenary session of this year’s virtual ASCO Annual Meeting showed the addition of 177Lu-PSMA-617 to standard care significantly extended OS and radiographic PFS among men with progressive prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.
The FDA previously granted breakthrough therapy designation to 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer.