Novartis said the FDA approved Pluvicto for use alongside hormone therapy in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), widening the eligible population beyond the previously approved post-chemotherapy castration-resistant setting. The expanded label would nearly double the pool of patients who can receive the radioligand. The approval brings Pluvicto across all stages of PSMA-positive metastatic prostate cancer, Novartis said, and uses data from the PSMAddition trial. In conjunction with standard of care (androgen receptor pathway inhibitor and ADT), the company reported a 28% reduction in risk of disease progression or death at primary analysis and a 33% reduction in an updated analysis, with an overall survival trend favoring Pluvicto. Safety, Novartis said, aligned with the established Pluvicto profile. The decision positions radioligand therapy earlier in the disease course, where treatment sequencing and long-term tolerability are central considerations for clinicians.