FDA approves new therapy for metastatic hormone-sensitive prostate cancer

The FDA has granted approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to treat PSMA-positive metastatic hormone-sensitive prostate cancer, when combined with an ARPI. This decision follows data from the Phase 3 PSMAddition trial, which demonstrated a 28% reduction in the risk of progression or death. The approval provides a new treatment option for patients facing this advanced form of prostate cancer.