Pluvicto (lutetium (177Lu) vipivotide tetraxetan) - (PSMAddition)

July 31, 2026: Novartis announced FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) plus an androgen receptor pathway inhibitor for PSMA-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer (mHSPC).

The approval is based on the Phase III PSMAddition trial. At the primary analysis, Pluvicto plus standard of care (ARPI + ADT) reduced the risk of progression or death by 28% versus standard of care alone (HR 0.72; 95% CI: 0.58–0.90). In an updated analysis, the reduction improved to 33% (HR 0.67; 95% CI: 0.55–0.82), with a positive overall survival trend favoring the Pluvicto combination (HR 0.80; 95% CI: 0.63–1.01) ahead of the final OS analysis.

Safety was consistent with prior studies (PSMAfore and VISION). Grade 3 or higher adverse events occurred in 50.7% of the Pluvicto arm versus 43.0% with standard of care alone; common all-grade adverse events were dry mouth, fatigue, nausea, hot flush, and anemia. Health-related quality of life was reported as maintained with similar outcomes across arms.

The company said Pluvicto is now approved across PSMA-positive metastatic prostate cancer and is also being studied in oligometastatic prostate cancer in PSMA-DC (NCT05939414).