The FDA expanded Novartis’ Pluvicto label, clearing the radioligand therapy for use alongside hormone therapy in an earlier setting of metastatic prostate cancer. The update nearly doubles the eligible patient population compared with prior indications by moving treatment into metastatic hormone-sensitive disease (PSMA-positive), rather than confining use to later castration-resistant stages. Regulators based the decision on data from the PSMAddition trial, where Pluvicto in combination with standard of care reduced the risk of disease progression or death versus standard of care alone, with additional analyses flagging favorable trends consistent with improved outcomes. With more than 80% of prostate cancer patients expressing PSMA, the label expansion increases the addressable clinical segment for PSMA-targeted theranostics and intensifies competitive dynamics in radiopharmaceutical oncology.