The production suspension will impact both the commercial and clinical trial supplies of Lutathera and Pluvicto in the United States and Canada.
Novartis has temporarily suspended production at its radioligand therapy production sites in Ivrea, Italy, and Millburn, N.J., because of a quality issue identified in the manufacturing processes of two products
As a result, the company has suspended delivery of Lutathera (lutetium Lu 177 dotatate) in the United States and Canada, and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in the United States. Some doses of Lutathera will be available in Europe and Asia from the company’s production site in Spain, although there may be some delays in supply.
Novartis is putting a temporary hold on enrollment for clinical trials of both therapies in the United States and Canada.
Novartis said it has taken this action out of an abundance of caution. The company is conducting a thorough review and expects to resolve the issues and resume some supply in the next six weeks.
“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,” the company said in a press release.
The FDA approved Pluvicto in March 2022 for the treatment of adult patients with metastatic prostate cancer, specifically patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
The FDA approved Lutathera in January 2018 for the treatment adults with a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).