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Novartis Pauses US Pluvicto Production Due to Possible Quality Issues

NEW YORK – Novartis said on Thursday that it has paused production of its radiopharmaceuticals Lutathera (lutetium Lu 177 dotatate) and Pluvicto (177Lu-PSMA-617) at manufacturing facilities in both Italy and New Jersey.

The firm said in a statement that the "action has been taken out of an abundance of caution as a result of potential quality issues identified in its manufacturing processes," but did not detail the specific quality issues.

The announcement comes just over a month after Novartis nabbed US Food and Drug Administration approval for Pluvicto as treatment for metastatic castration-resistant prostate cancer. The firm has been focusing on its targeted radiopharmaceutical pipeline as an area of growth and a driver of future revenues.

Novartis said it expects to resolve the issues in its facilities in Ivrea, Italy and Millburn, New Jersey, within six weeks, but the timeline may change based on an ongoing review. In pausing production, Novartis also has to stop distributing Lutathera and Pluvicto in the US and Canada. For Lutathera, the firm said there might be some doses still available in Europe and Asia coming from a separate manufacturing site in Spain, but there may still be supply delays.

As for clinical trials involving these agents, Novartis is putting a temporary hold on screening and enrollment across the US and Canada.

Novartis noted that "there is currently no indication of any risk to patients from doses previously produced at these sites," though the firm has asked treatment sites to monitor recently treated patients closely and to report any adverse events.

Following the announcement, shares of Novartis were down around 2 percent at $85.89 in Thursday afternoon trading on the Nasdaq.