FDA approves expanded indication for Pluvicto

The US Food and Drug Administration (FDA) has 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), Swiss pharma giant Novartis (NOVN: VX) revealed late Friday.

Approval is based on the Phase III PSMAddition 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.