FDA expands Pluvicto label for hormone-sensitive metastatic prostate cancer

Patients with metastatic hormone-sensitive prostate cancer are increasingly treated with combination therapy, yet many still progress to castration-resistant disease within two years. FDA has expanded the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer, making it the first targeted radioligand therapy approved for use this early in the metastatic disease course.

The approval moves radioligand therapy earlier in treatment, before resistance to hormone therapy develops. Until now, Pluvicto had been reserved for metastatic castration-resistant prostate cancer. For oncologists, this expands treatment options for eligible patients and underscores the growing role of PSMA testing in treatment selection.

The approval was based on the phase 3 PSMAddition trial. At the primary analysis, adding Pluvicto to standard therapy with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) reduced the risk of radiographic progression or death by 28% compared with standard therapy alone. With longer follow-up, the reduction improved to 33%. Overall survival also favored the Pluvicto group, although follow-up was not yet long enough to determine whether survival improved.

The safety profile was consistent with previous Pluvicto studies. Grade 3 or higher adverse events occurred in 50.7% of patients receiving Pluvicto plus standard therapy versus 43.0% receiving standard therapy alone. The most common adverse events were dry mouth, fatigue, nausea, hot flush, and anemia, while health-related quality of life was maintained throughout treatment.

The expanded indication will also require greater coordination between medical oncology, nuclear medicine, and imaging services as radioligand therapy becomes part of earlier treatment planning.

“The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters. Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients,” said Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and a principal investigator of the study in the United States.

Source: Novartis. (2026 Jul 31). FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease