The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The decision extends radioligand therapy earlier in disease, moving beyond the historically later-stage, castration-resistant setting. Regulatory review relied on results from the phase 3 PSMAddition trial (NCT04720157). In the study, adding Lu-177 vipivotide tetraxetan to standard-of-care ARPI plus androgen deprivation therapy (ADT) reduced the risk of progression or death by 28% versus SOC alone (HR 0.72; 95% CI 0.58–0.90). An updated analysis reported continued benefit (HR 0.67; 95% CI 0.55–0.82) with a positive—though not definitive—trend toward overall survival (HR 0.80; 95% CI 0.63–1.01). The label also requires confirming PSMA expression using Ga 68 gozetotide PET (Locametz) or another PET product. Memorial Sloan Kettering’s Michael Morris, MD, called the approval a meaningful expansion of treatment options at the mHSPC stage.