Production of Novartis’ radioligand therapy suspended

Novartis has announced a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey, US.

The company has taken this action out 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 enrolment for ¹⁷⁷Lu-PSMA-617 clinical trials globally and Lutathera clinical trials in the US and Canada.

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.

Novartis stated that it 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.