Novartis Suspends Production of Two Radioligand Drugs Due to Potential Quality Issues

Novartis announced on Thursday that it has suspended production of neuroendocrine tumor treatment Lutathera and recently FDA-approved prostate cancer treatment Pluvicto at its plants in Ivrea, Italy and Milburn, New Jersey.

Novartis took this step because a potential quality issue was identified during production. However, a company spokesman declined to provide further details on the quality issue.

Novartis has discontinued Lutathera to customers in the U.S. and Canada and Pluvicto to customers in the U.S. It is reported that Pluvicto was just approved by the US FDA in late March this year for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.

In addition, patient enrollment in clinical trials for Pluvicto worldwide has been discontinued, as has patient enrollment in clinical trials for Lutathera in the U.S. and Canada.

Novartis said there is currently no indication that patients who have been treated in these areas are at risk but the company still requires designated radioligand therapy centers to "closely monitor patients who have recently received injections" and report side effects. Regulators have also been notified, and Novartis is currently reviewing it. As for the timing of the resumption of production, Novartis said it expects to resolve the issue and restore some supplies within the next six weeks.

Meanwhile, Novartis remains operational at a radioligand therapy manufacturing site in Zaragoza, Spain, and is making Lutathera for Europe and Asia, but supply may be delayed.

Both Lutathera and Pluvicto are radioligand therapies, and are Novartis' blockbuster drugs. Radioligand therapy is a type of therapy in which a therapeutic radioisotope is conjugated to a cell-targeting compound (ligand). The radioisotopes are produced in special nuclear reactors, then conjugated to ligands at the production facility, and the finished product is packaged into special lead-shielded containers and shipped directly to the treatment site.

It's worth mentioning that this isn't the first time Novartis has struggled with its manufacturing. When Kymriah, a CAR-T cell therapy for blood cancers, was initially launched, the company faced a product that did not meet commercial specifications. That led doctors at the time to cut back on Kymriah in favor of Gilead Sciences' equivalent, Yescarta.