Novartis’ Pluvicto received an FDA label expansion to use alongside hormone therapy for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval effectively broadens the eligible population by nearly doubling the number of patients who can be treated with the radioligand therapy across disease stages. The agency approved Pluvicto in combination with androgen receptor pathway inhibitors (ARPIs) based on data from the PSMAddition trial, in which the Pluvicto combo reduced the risk of progression or death versus standard of care. Novartis reported risk reductions and an emerging overall survival signal, with safety consistent with the known Pluvicto profile. The update pushes Pluvicto further into earlier-line prostate cancer treatment, extending its reach beyond post-chemotherapy metastatic castration-resistant disease where it was first approved. With prostate cancer increasingly defined by biomarkers such as PSMA, the label move reinforces demand for companion diagnostics and nuclear medicine capacity.