Novartis restarts production of radioligand therapy

Novartis announced recently that it has restarted radioligand therapy (RLT) production at two different sites.

Basel, Switzerland-based Novartis on June 30 said that it restarted production in “early June” at its Ivrea, Italy, and Millburn, New Jersey, sites, according to a news release. The company had halted production in May due to what it cited as potential quality issues in its manufacturing processes.

Radioligand therapy harnesses the power of radioactive atoms and applies it to advanced cancers to deliver radiation to target cells anywhere in the body with the aim of limiting damage to surrounding tissues through a targeted approach. Radioligands are also used in positron emission tomography.

The company also resumed delivery of doses to patients in a phased approach ahead of its expected six-week timeframe.

“The company has remediated the issues that led to the temporary, voluntary suspension of production in May,” Novartis wrote in the release. “These issues did not affect patient safety, and no risk to patients from the doses previously produced at these sites was identified.”

Novartis has also restarted screening and enrollment for clinical trials with ¹⁷⁷Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in the U.S., in most countries globally, and clinical trials with Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the U.S. and Canada.

Additionally, the company said it will invest in the expansion of RLT production capabilities at both the Italy and New Jersey locations to support the growing demand for its RLT platform. It also intends to build a new radioligand manufacturing facility in Indianapolis, Indiana, that will be operational in 2023.

“We recognize that this situation has affected – and is still affecting – patients, their families and care teams,” Novartis said. “Product quality and patient safety remain the company’s top priorities. We expect that product supply may be initially limited, and we are working hard to resume full production capacity and meet patient demand as quickly as possible.

“We continue to communicate with health authorities, and they are aware that we have restarted production and that the delivery of patient doses has resumed.”