Pluvicto Approved by FDA in Combination with an ARPI for PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer – Novartis
Novartis announced the 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 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.
“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.” – Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and a Principal Investigator of the study in the US.
Pluvicto 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*1. 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 state2-6. The PSMA biomarker is present in more than 80% of patients with prostate cancer7-11.
“This approval signals a new era in the treatment of prostate cancer, representing a shift toward more targeted, early intervention. This milestone redefines prostate cancer care, ensuring that from day one of their metastatic diagnosis, men have a precision option.” – Gina Carithers, CEO and President of the Prostate Cancer Foundation.
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.
“Pluvicto is now approved across PSMA-positive metastatic prostate cancer, nearly doubling the number of patients who may benefit from this targeted approach. Patients with metastatic prostate cancer continue to face significant unmet need, underscoring the importance of introducing precision options earlier in the treatment journey. Backed by nearly a decade of leadership in radioligand therapy and continued investment in science and infrastructure, we are expanding this field and bringing its promise to more patients.” – Victor Bultó, President, US, Novartis.
