FDA Approves Novartis' Pluvicto Label Expansion, Doubling Patient Pool in Metastatic Hormone-Sensitive Prostate Cancer
The U.S. Food and Drug Administration (FDA) has expanded the approval of Novartis' radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan), marking a major milestone in prostate cancer care by moving the treatment earlier into the disease continuum. On July 31, 2026, the FDA approved Pluvicto in combination with an androgen receptor pathway inhibitor (ARPI) for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The approval came one month ahead of the FDA's goal date and is supported by data from the Phase III PSMAddition trial (NCT04720157). The trial demonstrated that adding Pluvicto to standard of care (SoC; ARPI plus androgen deprivation therapy) achieved a statistically significant radiographic progression-free survival (rPFS) benefit, reducing the risk of progression or death by 33% in an updated analysis.
Clinical Efficacy and Impact
Under the PSMAddition trial, 1,144 patients were randomized 1:1 to receive either Pluvicto plus standard of care or standard of care alone. Key findings include:
- rPFS Benefit: The addition of Pluvicto reduced the risk of radiographic progression or death by 28% in the initial analysis (HR 0.72; 95% CI: 0.58–0.90), which improved to a 33% risk reduction in a subsequent updated analysis (HR 0.67; 95% CI: 0.55–0.82).
- Overall Survival Trend: A positive overall survival (OS) trend was observed favoring the Pluvicto combination (HR 0.80; 95% CI: 0.63–1.01) as data continue to mature.
- Patient Pool Expansion: Because the PSMA biomarker is present in more than 80% of patients with prostate cancer, this earlier-stage approval nearly doubles the number of patients eligible for Pluvicto, building on its existing approval for metastatic castration-resistant prostate cancer (mCRPC).