Novartis suspends production of radioligand therapies due to potential quality issues
Novartis temporarily suspended production at two of its radioligand therapy production sites.
Novartis took the voluntary action “out of an abundance of caution as a result of potential quality issues” identified in the manufacturing process, a company-issued press release stated.
Suspension of production at the two sites — one in New Jersey and one in Italy — will effect commercial and clinical trial supply of lutetium Lu 177 dotatate (Lutathera, Novartis) and lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis).
Delivery of both therapies will be suspended temporarily in the United States.
Novartis also placed a temporary hold on screening and enrollment of clinical trials for lutetium Lu 177 vipivotide tetraxetan around the world, as well as for clinical trials of lutetium Lu 177 dotatate in the United States and Canada.
The company expects to have the quality issues resolved to allow for resumption of some supply of these therapies within 6 weeks, according to the release.
“Quality and patient safety are our top priorities,” the company release stated. “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,” the release continued. “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.”
In March, the FDA approved lutetium Lu 177 vipivotide tetraxetan for treatment of men with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who received prior androgen receptor pathway inhibition and taxane-based chemotherapy.
Lutetium Lu 177 dotatate is approved in the United States for treatment of adults with gastroenteropancreatic neuroendocrine tumors that are positive for the hormone receptor somatostatin.