Novartis Halts Production of Radioligand Therapies Lutathera and Pluvicto Due to Potential Quality Issues

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On Thursday, Novartis announced that the company has suspended production of Lutathera, a treatment for neuroendocrine tumors, and Pluvicto, a recently FDA-approved prostate cancer treatment, at its plants in Ivrea, Italy, and Millburn, New Jersey.

Novartis took this measure because potential quality issues were discovered during the production process. However, the company spokesperson refused to provide more details about the quality issues.

Currently, Novartis has stopped supplying Lutathera to customers in the United States and Canada, as well as Pluvicto to customers in the United States. It is reported that Pluvicto was just approved by the U.S. FDA in late March this year for treating PSMA-positive metastatic castration-resistant prostate cancer, with an expected peak sales of up to $2 billion. However, the supply suspension occurred merely six weeks later.

In addition, the enrollment of patients in clinical trials for Pluvicto has been halted globally, and the enrollment of patients in clinical trials for Lutathera has also been stopped in the United States and Canada.

Novartis stated that there is currently no indication of risks for patients who have been treated in these areas, but the company still requires designated radioligand therapy centers to "closely monitor patients recently injected with the treatment" and report any adverse effects. Regulatory authorities have also been notified, and Novartis is currently conducting a review. As for the timeline to resume production, Novartis stated that it expects to resolve the issue and restore partial supply within the next six weeks.

Meanwhile, Novartis' radioligand therapy production site in Zaragoza, Spain, remains operational and is producing Lutathera for Europe and Asia, but there may be delays in supply.

Lutathera and Pluvicto are both radioligand therapies and key drugs of Novartis. Radioligand therapy is a class of treatment that conjugates therapeutic radioisotopes with cell-targeting compounds (ligands). The radioisotopes are produced in special nuclear reactors, then conjugated with ligands at the production facility. The finished product is packaged into specially lead-shielded containers and directly shipped to the treatment location.

It is worth mentioning that this is not the first time Novartis has encountered difficulties in its manufacturing. When the CAR-T cell therapy Kymriah, aimed at blood cancers, was initially launched, the company faced issues with the product not meeting commercial specifications. This led to doctors at the time reducing their use of Kymriah and instead favoring a similar product from Gilead Sciences, Yescarta.

Reference Source:

1、Novartis halts US production of radioligand cancer therapies, citing potential quality issues

2、Novartis Stops Production of Cancer Drugs Over Quality Concerns