Novartis’ Pluvicto received FDA clearance in an earlier prostate cancer stage, in tandem with an androgen receptor pathway inhibitor, for patients with PSMA-positive metastatic hormone-sensitive prostate cancer. The move follows earlier FDA decisions that advanced Pluvicto stepwise through the treatment landscape, with Novartis positioning the latest approval as a broadening of radioligand therapy across stages. The approval is anchored in the phase 3 PSMAddition program, where Pluvicto plus standard-of-care ARPI and ADT reduced the risk of progression or death. Novartis also highlighted subgroup and updated analyses suggesting continued benefit durability, alongside safety data comparable to known radioligand therapy adverse-event patterns. Industry observers will now look to how quickly PSMA testing and PET workflows can support broader adoption, particularly as earlier use tends to increase eligible patient volumes and treatment sequencing discussions with ARPI and ADT backbones.