FDA Approves Expanded Use of Pluvicto for Earlier-Stage Metastatic Prostate Cancer

The U.S. FDA has expanded the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include patients with PSMA-positive metastatic hormone-sensitive prostate cancer. This marks the first targeted radioligand therapy approved for use earlier in the metastatic disease course, offering a new treatment option before resistance to hormone therapy develops. Based on the Phase 3 PSMAddition trial, adding Pluvicto to standard therapy reduced the risk of radiographic progression or death by up to 33%.