FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for PSMA+ mHSPC

The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic androgen pathway modulation–naive/sensitive prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC).^1,2

This regulatory decision was based on data from the phase 3 PSMAddition trial, in which treatment with lutetium Lu 177 vipivotide tetraxetan in combination with standard-of-care ARPI plus androgen deprivation therapy (ADT) led to a 28% reduction in the risk of progression or death vs SOC therapy alone (HR, 0.72; 95% CI, 0.58-0.90). An updated analysis showed that the lutetium Lu 177 vipivotide tetraxetan regimen further reduced the risk of progression or death (HR, 0.67; 95% CI, 0.55-0.82), and showed a positive trend toward improved OS outcomes (HR, 0.80; 95% CI, 0.63-1.01). Notably, data will continue to mature before the final OS analysis.

Eligibility for lutetium Lu 177 vipivotide tetraxetan in patients with mHSPC should be determined using gallium Ga 68 gozetotide (Locametz) or another PET product based on tumor PSMA expression levels.²

“The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters,” Michael Morris, MD, section head of Prostate Cancer and GU Oncology at Memorial Sloan Kettering Cancer Center in New York, New York, as well as a principal investigator of the PSMAddition trial in the United States, stated in a news release.¹ “Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients.”

References

1. FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease. News release. Novartis. July 31, 2026. Accessed July 31, 2026. https://www.novartis.com/news/media-releases/fda-approves-pluvicto-psma-metastatic-hormone-sensitive-prostate-cancer-mhspc-advancing-potential-new-standard-care-across-metastatic-disease
2. FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. FDA. July 31, 2026. Accessed July 31, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy