Novartis Pharma AG: FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing 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
  
  

Basel, July 31, 2026 - 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 state^2-6. The PSMA biomarker is present in more than 80% of patients with prostate cancer^7-11.

"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."

Novartis RLT Patient and Office Support
With five manufacturing sites now operational or under construction in the US, Novartis has established an industry-leading footprint to support its goal of establishing RLT as a fundamental pillar of oncology care. Backed by an integrated end-to-end RLT ecosystem, Novartis can deliver Pluvicto to US treatment sites within 5 days to ensure prompt treatment initiation.

Novartis Patient Support is available to help eligible patients get started on treatment, including help understanding insurance coverage and identifying potential financial assistance options. Patients or providers can speak to a live agent at 1-844-638-7222 or visit https://us.pluvicto.com/support/novartis-patient-support.

About Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
Pluvicto is an intravenous radioligand therapy (RLT) combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

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

Radioligand Therapy (RLT) at Novartis
Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation, RLT is designed to deliver treatment directly to target cells anywhere in the body.

As a global leader in this space, Novartis has built integrated capabilities across research, manufacturing, logistics, and patient and provider support to help ensure approved RLTs reach patients reliably and efficiently. Novartis is investigating a broad portfolio of isotopes, ligands, and combination therapies to expand the use of RLT beyond prostate and neuroendocrine tumors.

Disclaimer
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About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

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*Global incidence includes the United States, China, Japan, France, Germany, Italy, Spain and the United Kingdom.

References

1. Novartis data on file.
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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.
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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.
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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.
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