FDA has expanded the indication for Novartis’ radioligand therapy Pluvicto into an earlier stage of prostate cancer, approving it for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) in combination with an androgen receptor pathway inhibitor (ARPI). The approval is based on data from the phase 3 PSMAddition trial (NCT04720157), where the combination reduced the risk of progression or death versus ARPI plus androgen deprivation therapy (ADT) alone. In the primary analysis, PSMAddition reported a 28% reduction (HR 0.72), with an updated analysis showing a 33% reduction (HR 0.67) and a positive overall survival trend. Novartis said the expanded label nearly doubles the eligible patient population for PSMA-positive metastatic disease, reflecting broader use earlier in the treatment pathway. Clinicians will also determine eligibility using PSMA PET imaging. The expanded use widens a commercially important franchise and increases the urgency of sequencing radioligand therapy within evolving frontline prostate cancer treatment standards.