FDA cleared lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), extending radioligand therapy into the earlier disease setting. The approval was supported by the phase 3 PSMAddition trial (NCT04720157). In PSMAddition, the regimen reduced the risk of progression or death by 28% versus standard-of-care therapy alone (HR 0.72; 95% CI 0.58–0.90). An updated analysis showed further improvement on progression or death (HR 0.67; 95% CI 0.55–0.82), with a positive OS trend reported though final overall survival data are still maturing. The FDA decision also ties eligibility to imaging confirmation using gallium Ga 68 gozetotide (Locametz) or another PET product to determine PSMA expression levels. Memorial Sloan Kettering investigator Michael Morris, MD, said the approval “expands the options” for clinicians and reflects that earlier intensification matters in mHSPC. For companies developing PSMA-targeted agents, the ruling raises the bar for future trials by demonstrating a regulator-supported path for radioligand therapy in hormone-sensitive disease.