- Novartis has temporarily suspended production of Lutathera® and Pluvicto™/ 177Lu-PSMA-617 at facilities in Ivrea, Italy and Millburn, New Jersey
- This action has been taken out of an abundance of caution as a result of potential quality issues identified in its manufacturing processes
- The production suspension impacts commercial and clinical trial supply
- Current expectation is resolution of these issues, and resumption of some supply, within 6 weeks; subject to confirmation via an ongoing review
Basel, May 5, 2022 — Novartis today announced a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey. The company has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes. Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.
As a result, the company is temporarily suspending delivery of Lutathera® (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada, and 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) in the US. Some doses of Lutathera® (lutetium (177Lu) oxodotreotide) will be available in Europe and Asia from Novartis radioligand therapy production site in Zaragoza, Spain, although there may be some delays in supply.
In addition, Novartis is putting a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.
Quality and patient safety are our top priorities. There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety.
We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible. Health authorities have been informed and will receive additional updates as they are available.
Disclaimer
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