FDA Approves Pluvicto for PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). This approval is based on the Phase III PSMAddition trial, which demonstrated that Pluvicto reduced the risk of progression or death by 33% when combined with standard of care.