Novartis announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post-taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions, as determined by the FDA.1