- Production and phased deliveries of patient doses resumed in early June
- Screening and enrollment have restarted for 177Lu-PSMA-617 and Lutathera® clinical trials
- Expanding radioligand therapy manufacturing capacity globally to support demand
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 US, in most countries globally, and clinical trials with Lutathera® (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada.
In addition, to support the growing demand for our RLT platform, Novartis is investing in the expansion of RLT production capabilities in both Millburn and Ivrea, as well as building 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. 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.
Source: "Novartis Resumes Production And Delivery Of Radioligand Therapy Medicines Ahead Of Schedule". 2022. Novartis.