Basel, Switzerland- January 2024- Novartis has gained approval from the US Food and Drug Administration (FDA) for the commercial manufacturing of PluvictoTM (lutetium (177Lu) vipivotide tetraxetan) at its newly inaugurated radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana. This 70,000-square-foot site, now the largest and most advanced in the Novartis global network, marks a significant step in RLT manufacturing growth, ensuring substantial supply increases for the foreseeable future.
“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis. “Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come. We also recently announced plans to build our manufacturing capabilities in Sasayama, Japan and Haiyan, Zhejiang, China, as we continue to look for opportunities to further expand our worldwide reach.”
The purpose-built Indianapolis facility is designed for current and future RLT manufacturing needs, featuring space for continued line expansion, including plans for fully automated lines—a first for the radiopharmaceutical industry. This site will supply the growing demand for patients in the US and potentially Canada upon approval. Novartis’ Millburn, New Jersey location will complement this supply, while the Ivrea, Italy, and Zaragoza, Spain facilities will serve patients globally.
Novartis has significantly increased Pluvicto production, ensuring an unconstrained supply. With doubled weekly production, the company has more than enough supply to treat patients within two weeks of diagnosis, a critical factor for those with advanced diseases requiring swift treatment.
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The commitment to improving access includes plans to add more treatment sites in closer proximity to patients in the coming months. With four active manufacturing facilities and a production capacity of 250,000 doses in 2024 and beyond, Novartis aims to expand its worldwide RLT manufacturing network, potentially bringing Pluvicto and Lutathera to more patients in earlier lines of treatment based on ongoing clinical trials.
