FDA Expands Pluvicto Approval for Earlier-Stage Metastatic Prostate Cancer

The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) when combined with an ARPI. This decision, based on the Phase III PSMAddition trial, expands the precision treatment to an earlier disease stage, potentially doubling the eligible patient population and offering a new standard of care.