SWITZERLAND – Novartis plans to start commercial production of Pluvicto at its large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in the United States of America.
In a news release, the company said: “Novartis is committed to expanding the radioligand therapy platform to shape the future of RLT as a treatment class.”
By harnessing the power of radioactive atoms and applying it to advanced cancers, RLT is theoretically able to deliver radiation to target cells anywhere in the body.
The opening of the Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.
In his address, Steffen Lang, President of Operations at Novartis, said: “Adding a second US RLT facility into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come.”
Steffen Lang further said that 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.
Covering an area of 70,000 square feet in Indianapolis, Indiana, the manufacturing facility becomes the largest and most advanced Novartis facility of its kind in the world.
The Indianapolis site will allow the company to expand its manufacturing capacity in a strategic move to meet growing demand of Pluvicto, enter new markets, and diversify its product portfolio.
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, by adding more treatment sites in closer proximity to patients over the coming months.
With approval from the US Food and Drug Administration (FDA), Novartis is looking to create space for continued line expansion, including plans for fully automated lines, a first for the radiopharmaceutical industry.
FDA approval of the company’s second US Radioligand Therapy (RLT) manufacturing facility increases RLT production capacity to 250,000 doses in 2024 and beyond.
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.
Moreover, the company’s Italian will continue to supply patients in and outside the US while the company’s facility in Zaragoza, Spain will solely provide RLTs for patients outside the US.
The Indianapolis site, designed specifically for RLT manufacturing, comes as Novartis has accelerated plans to shift some of its production outside Switzerland.
For his part, Lang confirmed: “Our production capabilities continue to expand and now include sites in Millburn, US, Zaragoza, Spain, Ivrea, Italy and our new state-of-the-art facility in Indianapolis, US. We are continually evaluating additional opportunities to increase capacity around the world.”
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.
This expansion will prove pivotal as the company’s ongoing clinical trials may present the potential to bring Pluvicto and Lutathera to more patients in earlier lines of treatment.
Novartis recently presented data at the 2023 European Society for Medical Oncology Congress studying Pluvicto in the pre-taxane setting for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
“We are investigating a broad portfolio of RLTs, exploring new isotopes, ligands and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and prostate cancer and into breast, colon, lung and pancreatic cancer,” stated Lang.
In addition to the company’s second US location, Novartis plans to build its manufacturing capabilities in different places around the world, including Sasayama, Japan, Zhejiang, China, and Haiyan.
The company aims to expand its manufacturing capabilities and build additional points of supply to produce RLTs for patients in Japan and China.
“With established global expertise, specialized supply chain, and manufacturing capabilities across its network, we are supporting growing demand for our RLT medicines,” added Lang.