The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), expanding radioligand therapy into the hormone-sensitive stage. The decision is based on results from the phase 3 PSMAddition trial (NCT04720157). In the trial, adding the radioligand to standard-of-care ARPI plus androgen deprivation therapy (ADT) produced a 28% reduction in risk of progression or death versus SOC alone (HR 0.72; 95% CI 0.58–0.90). An updated analysis showed a further reduction in progression-or-death risk (HR 0.67; 95% CI 0.55–0.82) and a favorable trend toward improved overall survival. The FDA’s label ties patient selection to PSMA positivity assessed by Ga 68 gozetotide (Locametz) PET or another PSMA PET product, reflecting the need for companion diagnostic-type alignment for eligibility. Clinicians at Memorial Sloan Kettering, including PSMAddition principal investigator Michael Morris, said the approval meaningfully broadens options in a setting where intensification earlier in the disease course can change outcomes.