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FDA Approves Pluvicto for PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

FDA Approves Pluvicto for PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Advancing a Potential New Standard of Care Across Metastatic Disease

  • Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population
  • PSMAddition updated results show Pluvicto reduced risk of progression or death by 33% in combination with standard of care (ADT + ARPI) vs. SoC alone, with positive overall survival trend (HR=0.80)
  • mHSPC is incurable and about half of men progress within 20 months, highlighting need for differentiated, precision approaches earlier in disease journey
  • With five US RLT manufacturing sites operational or under construction, Novartis has scale and infrastructure to meet growing demand

Las Vegas, Nevada (UroToday.com) -- Novartis today announced the US Food and Drug Administration (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,” said Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and a Principal Investigator of the study in the US. “Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients.” 

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," said Gina Carithers, CEO and President of the Prostate Cancer Foundation. "This milestone redefines prostate cancer care, ensuring that from day one of their metastatic diagnosis, men have a precision option."

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," said Victor Bultó, President, US, Novartis. "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."

Pluvicto is the only PSMA-targeted agent approved across metastatic prostate cancer. Novartis is also investigating Pluvicto in oligometastatic prostate cancer (PSMA-DC, NCT05939414).

References

  1. Novartis data on file.
  2. Armstrong AJ, et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986.
  3. Verry C, Vincendeau S, Massetti M, et al. Pattern of clinical progression until metastatic castration-resistant prostate cancer: an epidemiological study from the European Prostate Cancer Registry. Target Oncol. 2022;17(4):441-451.
  4. Wenzel M, Siech C, Hoeh B, et al. Contemporary treatment patterns and oncological outcomes of metastatic hormone-sensitive prostate cancer and first- to sixth- line metastatic castration-resistant prostate cancer patients. Eur Urol Open Sci. 2024;66:46-54.
  5. Freedland SJ, Davis M, Epstein AJ, Arondekar B, Ivanova JI. Real-world treatment patterns and overall survival among men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in the US Medicare population. Prostate Cancer Prostatic Dis. 2024;27(2):327-333.
  6. Holmstrom S, Naidoo S, Turnbull J, et al. Symptoms and impacts in metastatic castration-resistant prostate cancer: qualitative findings from patient and physician interviews. Patient. 2019;12(1):57-67.
  7. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623.
  8. Bostwick DG, Pacelli A, Blute M, et al. Prostate specific membrane antigen expression in prostatic intraepithelial neoplasia and adenocarcinoma: a study of 184 cases. Cancer. 1998;82(11):2256-2261.
  9. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is associated with early PSA recurrence in surgically treated prostate cancer. Prostate. 2011;71(3):281-288.
  10. Hope TA, Aggarwal R, Chee B, et al. Impact of 68Ga-PSMA-11 PET on management in patients with biochemically recurrent prostate cancer. J Nucl Med. 2017;58(12):1956-1961.
  11. Pomykala KL, Czernin J, Grogan TR, et al. Total-body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. J Nucl Med. 2020;61(3):405-411.


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

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