FDA Approves Novartis Pluvicto for mHSPC

The U.S. United States — Food and Drug Administration approved Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on the Phase III PSMAddition trial, which showed Pluvicto reduced the risk of progression or death by 28% (HR 0.72) when added to standard of care, and by 33% (HR 0.67) in an updated analysis, with a positive overall survival trend (HR 0.80). This approval expands Pluvicto's use across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. Pluvicto remains the only PSMA-targeted therapy approved across metastatic prostate cancer. Novartis is also investigating its potential in oligometastatic prostate cancer. The approval was announced on July 31, 2026, and Novartis' stock closed down 1.45% on the day.