FDA Expands Pluvicto to Earlier-Stage Hormone-Sensitive Prostate Cancer, Nearly Doubling Eligible Patients

The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer — previously called metastatic hormone-sensitive prostate cancer (mHSPC) — moving the PSMA-targeted radioligand therapy into an earlier disease stage before castration resistance develops. The approval is based on the Phase 3 PSMAddition trial, which showed Pluvicto plus standard of care reduced the risk of radiographic progression or death by 28% (HR 0.72) versus standard of care alone, with favorable but still-immature overall survival trends. Grade 3+ adverse events were higher in the Pluvicto arm (50.7% vs. 43%), with anemia, dry mouth, and fatigue most common. This is Pluvicto's third FDA approval milestone since its initial 2022 clearance and roughly doubles the pool of eligible prostate cancer patients.