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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
Currently, Novartis has discontinued Lutathera to customers in the U.
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.
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
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
It's worth mentioning that this isn't the first time Novartis has struggled with its manufacturing
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