FDA Approves Pluvicto for Metastatic Prostate Cancer, Expanding Treatment Options
The U.S. Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). This approval allows Pluvicto to be used in combination with an androgen receptor pathway inhibitor (ARPI) and standard care, nearly doubling the eligible patient population. The decision 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 care, compared to standard care alone. This marks a significant advancement in the treatment landscape for mHSPC, which is incurable and often progresses within 20 months. The approval reflects a shift towards earlier treatment intensification, offering a precision option from the onset of metastatic diagnosis. 
