FDA Approves Expanded Use of Pluvicto for Early Metastatic Prostate Cancer

The U.S. FDA has expanded the approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include patients with PSMA-positive metastatic hormone-sensitive prostate cancer. This makes Pluvicto the first targeted radioligand therapy approved for earlier use in the metastatic disease course, before hormone therapy resistance develops. The decision is based on the Phase 3 PSMAddition trial, which showed a 28% reduction in the risk of radiographic progression or death when added to standard therapy.