The FDA approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for men with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The new label moves the treatment into an earlier manifestation of the disease, expanding use beyond Pluvicto’s prior indication in metastatic castration-resistant prostate cancer. Regulators based the approval on data from the phase 3 PSMAddition trial (NCT04720157), reporting a 28% reduction in risk of progression or death versus androgen receptor pathway inhibitor plus androgen deprivation therapy alone. An updated analysis showed further risk reduction and a positive overall survival trend, with safety consistent with Pluvicto’s established profile. Eligibility will require confirmation of PSMA expression using Ga 68 gozetotide (Locametz) or another approved PET product. Novartis said the expansion nearly doubles the addressable PSMA-positive metastatic prostate cancer population, adding momentum toward peak-sales expectations.