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New State-of-the-Art Radioligand Therapy Facility in Indianapolis by Novartis

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Novartis, a global leader in pharmaceuticals, has achieved a significant milestone with the FDA approval of its second US Radioligand Therapy (RLT) manufacturing facility, signaling a major expansion in the company’s production capabilities. This new facility in Indianapolis, Indiana, is set to dramatically increase the production capacity of RLTs, aiming to reach 250,000 doses in 2024 and beyond.

The new 70,000-square-foot facility, located centrally in the US, is the largest and most advanced Radioligand Therapy facility of Novartis to date. It is specifically designed for RLT manufacturing and represents a pivotal step in the company’s strategy to enhance access to these therapies for patients and treatment centers across the country.

Novartis’ commitment to RLT, a promising treatment class for advanced cancers, is evident in its investment in this state-of-the-art facility. The Indianapolis site will play a crucial role in supplying the increasing demand for RLTs in the US and potentially in Canada, upon approval. It complements the existing Millburn, New Jersey facility and other international sites in Ivrea, Italy, and Zaragoza, Spain, which supply RLTs globally.

Novartis Reinforces Commitment to Radioligand Therapy with Advanced Indianapolis Facility and Global Network Expansion

The Indianapolis facility is purpose-built for manufacturing current and future RLTs. It includes space for ongoing line expansion, including plans for fully automated lines, marking a first in the radiopharmaceutical industry. This facility is crucial for supplying the growing demand for RLTs, especially for patients in the US who require timely treatment for advanced diseases.

Novartis has recently announced that the supply of its RLT product, Pluvicto, is now unconstrained. The company has successfully doubled its weekly production, ensuring a swift treatment process for patients diagnosed with advanced diseases. In addition to Pluvicto, Novartis produces Lutathera, another RLT medicine, at these facilities. By expanding treatment sites closer to patients, Novartis aims to improve access to its RLTs over the coming months.

With ongoing clinical trials, Novartis foresees the potential to extend the use of Pluvicto and Lutathera to more patients and in earlier treatment lines. The company’s commitment to RLT as a treatment class is further demonstrated by its broad portfolio of RLTs under investigation for various cancers, including breast, colon, lung, pancreatic, and prostate cancers. At the 2023 European Society for Medical Oncology (ESMO) Congress, Novartis presented data on Pluvicto for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistance prostate cancer (mCRPC) in the pre-taxane setting.

Radioligand Therapy


New Facilities in Japan and China to Meet Rising Global Demand

Novartis is also expanding its global RLT manufacturing network with plans to build additional facilities in Sasayama, Japan, and Haiyan, Zhejiang, China. These new sites will produce RLTs for patients in Japan and China, highlighting the company’s commitment to meeting the growing global demand for these therapies.

In summary, Novartis’ new facility in Indianapolis represents a significant advancement in the company’s RLT production capabilities. It not only underscores Novartis’ commitment to expanding access to these innovative therapies but also reflects the company’s foresight in anticipating and meeting future demands in the treatment of various advanced cancers. With a network of facilities across the globe, Novartis is well-positioned to continue its leadership in the field of radioligand therapy.


Resource: Novartis, January 05, 2023

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