FDA Expands Pluvicto Approval for Earlier Use in Metastatic Hormone-Sensitive Prostate Cancer

The U.S. Food and Drug Administration (FDA) has expanded the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), allowing its use in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer. This approval marks Pluvicto as the first targeted radioligand therapy to be used earlier in the metastatic disease course, moving its application before resistance to hormone therapy develops. The decision is based on results from the phase 3 PSMAddition trial, which showed that adding Pluvicto to standard therapy reduced the risk of radiographic progression or death by 28%, improving to 33% with longer follow-up.