FDA Approves Pluvicto for Expanded Use in Metastatic Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved Pluvicto, a radioligand therapy developed by Novartis, for use in 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, in combination with standard care, significantly reduces the risk of disease progression or death. The therapy is now available for use across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. This marks a significant advancement in the treatment landscape for mHSPC, offering a new precision approach for early intervention.