On Jul. 31, 2026, Novartis announced the US Food and Drug Administration (FDA) approved Pluvicto^® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC). 

Approval is based on the Phase III PSM Addition trial, which showed Pluvicto reduced the risk of progression or death by 28% (HR 0.72; 95% CI: 0.58–0.90) when combined with standard of care (SoC; ARPI + androgen deprivation therapy [ADT]) compared to SoC alone. At a subsequent updated analysis, the Pluvicto combination further reduced the risk of progression or death by 33% (HR 0.67; 95% CI: 0.55–0.82) with a positive overall survival (OS) trend favoring Pluvicto plus SoC (HR=0.80; 95% CI: 0.63–1.01), as data continue to mature ahead of final OS analysis.

luvicto can now be used across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. The approval builds on its established use in metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer, also known as metastatic castration-resistant prostate cancer (mCRPC).

More than 186,000 men are diagnosed each year with mHSPC globally. Despite significant treatment advancements, about a third of patients do not achieve undetectable PSA with ARPI-ADT doublet therapy alone and half will progress to castration-resistant disease within 20 months, highlighting the need for earlier treatment intensification in this disease state. The PSMA biomarker is present in more than 80% of patients with prostate cancer

The safety profile and tolerability of Pluvicto were consistent with its established profile in PSMAfore and VISION. At primary analysis, grade ≥3 adverse events (AEs) were reported in 50.7% of patients who received Pluvicto plus SoC compared to 43.0% receiving SoC alone. The most common all-grade AEs were dry mouth, fatigue, nausea, hot flush and anemia. Health-related quality of life was maintained based on longitudinal assessment reflecting patient experience over time, with similar outcomes across arms in PSMAddition.