The U.S. FDA approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for metastatic hormone-sensitive prostate cancer (mHSPC) on July 31, 2024, moving the treatment into an earlier line. The decision was based on the Phase III PSMAddition trial, where adding Pluvicto to an androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy cut the risk of progression or death by 28% in the primary analysis and 33% in an updated analysis. Overall survival trended in favor of the Pluvicto arm, but the data are not yet mature.