Novartis announced that it has received approval from the FDA for commercial manufacturing of PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States. The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world. The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.
The Indianapolis facility, centrally located within the US, is purpose-built from the ground up to manufacture RLTs now and into the future and includes space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry. The new site will supply the growing demand for patients in the US and eventually in Canada, upon approval, together with the company’s Millburn, New Jersey location. The site in Ivrea, Italy will continue to supply patients in and outside the US while the facility in Zaragoza, Spain will solely provide RLTs for patients outside the US.
Novartis recently announced that supply of Pluvicto is unconstrained. Having doubled weekly production, Novartis currently has more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly.
Novartis is committed to improving access to its RLTs, Pluvicto and Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) by adding more treatment sites in closer proximity to patients over the coming months.
With four active manufacturing facilities, and a RLT production capacity of 250,000 doses in 2024 and beyond, Novartis continues to expand its worldwide RLT manufacturing network as ongoing clinical trials may present the potential to bring Pluvicto and Lutathera to more patients in earlier lines of treatment.
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