Novartis pauses production of cancer meds over quality issues

Novartis pumped the brakes on manufacturing two of its radioligand cancer drugs thanks to potential quality issues, the company said.

After problems with quality popped up, the pharma giant stopped production of Lutathera and Pluvicto at sites in Ivrea, Italy, and Millburn, New Jersey. Deliveries of Lutathera and Pluvicto will be paused to the U.S., and the U.S. and Canada, respectively until the problem is resolved. 

The company says the pause comes out of “an abundance of caution” and that it is working with the U.S. FDA as it looks to resolve the problem. Novartis did not specify what the problem was but did say that there was currently no risk to patients who had been previously dosed. The company will conduct a review and expects to resolve the problem within six weeks.

Lutathera, approved by the FDA in 2018, consists of a radioactive isotope, Lu-177, attached to dotatate — a molecule that binds to certain GEP-NET cells. It is used to treat neuroendocrine tumors. Pluvicto is Novartis’ freshly approved precision cancer treatment for patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.

Dosing in clinical trials of the drug have been paused in the U.S. and Canada as the company waits to review the situation. Some doses of Lutathera were produced at Novartis’ site in Zaragoza, Spain and will be available in Europe and Asia, although Novartis says to expect supply chain delays.