Press Release: FDA approves Novartis radioligand -2-

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at any particular time. Nor can there be any guarantee that Pluvicto will be commercially successful in the future. In particular, our expectations regarding Pluvicto could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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 nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com/ https://www.novartis.com and connect with us on https://www.linkedin.com/company/novartis/ LinkedIn, https://www.facebook.com/novartis/ Facebook, https://twitter.com/Novartis X/Twitter and https://instagram.com/novartis?igshid=MzRlODBiNWFlZA==__;!!N3hqHg43uw!pjp8z253J5NjaOYrW65UbAAlHeHRdQ-w0m4ezZxEQEl0ptafXN2M99VRIk39pf49PAc8NbK93Pxp3uaSBQkAf8oEnzWXG8Sk$ Instagram.

Disclosure: Dr. Sartor was involved in the design of the clinical trial and was chairman of the steering committee for the trial. Dr. Sartor is a paid consultant for Novartis, with payments made directly to Mayo Clinic.

References

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D, et al. RealWorld Treatment Patterns and Overall Survival of Patients

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PARP Inhibitors. Adv Ther. 2021;38(8):4520-40.

2. American Cancer Society. Key statistics for prostate cancer. Accessed

January 21, 2025.

https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html

3. Shore N, Heidenreich A, Saad F. Predicting response and recognizing

resistance: improving outcomes in patients with castration-resistant

prostate cancer. Urology 2017;109:6--18.

[https://pubmed.ncbi.nlm.nih.gov/28797685/]

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Taxanes Versus Androgen Receptor Therapy as Second-Line Treatment for

Castrate-Resistant Metastatic Prostate Cancer After First-Line Androgen

Receptor Therapy. Clin Genitourin Cancer. 2023;21(3):349-56.e2.

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[https://uroweb.org/guideline/prostate-cancer]

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[https://www.nccn.org]

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[https://www.esmo.org/guidelines/pocket-guidelines-mobile-app]

8. Moreira DM, Howard LE, Sourbeer KN et al. Predicting time from metastasis

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[https://pubmed.ncbi.nlm.nih.gov/27692812/]

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FDA approves Novartis radioligand therapy Pluvicto(R) for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

(END) Dow Jones Newswires

March 28, 2025 12:52 ET (16:52 GMT)