Novartis provides update on production of radioligand therapy medicines.
Novartis 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.
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