Novartis Begins Building Two US Radioligand Therapy Manufacturing Sites

Novartis has initiated the construction of two new facilities aimed at enhancing its production capabilities for radioligand therapy (RLT) products, Pluvicto and Lutathera. The company will invest over $200 million to support these expansions, as reported by various media outlets. This initiative underscores Novartis’ commitment to maintaining its leading position in the targeted radiotherapy market.

One of the new facilities will be located in Carlsbad, California. This site will be Novartis’ third RLT production facility in the United States. According to the company, the Carlsbad site will facilitate the expanded use of radioligand therapies, bolster the resiliency of its manufacturing network, and optimize the delivery of medicines to patients on the West Coast.

In addition to the new California site, Novartis is also expanding its facility in Indianapolis. This expansion will enhance the company’s capacity to produce radioisotopes, which are crucial components in the manufacturing of radioligand therapies.

Victor Bultó, President of Novartis U.S., emphasized the importance of these investments. He stated that bolstering the supply chain capabilities now will ensure the consistent delivery of complex treatments to a growing number of eligible patients in the future. Novartis has been a pioneer in the RLT field, being the first pharmaceutical company to provide these therapies on a large scale. Their targeted radiotherapies serve a broad range of cancer indications.

Lutathera, one of Novartis’ key RLT products, utilizes a lutetium-177 payload. It was first approved in January 2018 for treating gastroenteropancreatic neuroendocrine tumors (GEP-NET). In April 2024, Lutathera gained another approval, becoming the first treatment specifically indicated for pediatric patients with GEP-NETs. The drug generated over $600 million in revenue in 2023, marking a 28% increase from the previous year.

Another significant product, Pluvicto, is also based on lutetium-177. It is indicated for patients with metastatic castration-resistant prostate cancer who test positive for the PSMA protein. Approved in March 2022, Pluvicto is the first targeted RLT for advanced prostate cancer. Its sales in 2023 surged by more than 260%, totaling $980 million.

Novartis is not resting on its laurels with Lutathera and Pluvicto. The company aims to broaden Pluvicto’s use in prostate cancer treatment, specifically targeting patients who have not undergone chemotherapy. Data from the Phase III PSMAfore study suggested that Pluvicto could improve overall survival in this patient subgroup.

Beyond these two established products, Novartis is also developing several investigational radioligand therapies. These potential treatments are directed at various cancers, including breast cancer, pancreatic cancer, and other solid tumors. Although most of these investigational therapies are still in the early stages of development, they represent the company’s ongoing efforts to innovate and expand its RLT portfolio.

In conclusion, Novartis’ substantial investment in new and expanded manufacturing facilities signals a robust commitment to advancing the field of radioligand therapy. By increasing production capacity and enhancing supply chain resiliency, the company aims to ensure the long-term availability of these critical cancer treatments.

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