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Novartis suspends two cancer therapies over quality concerns


ZURICH (Reuters) – Novartis said on May 5 it had temporarily suspended the production of its Lutathera and Pluvicto cancer therapies at facilities in Italy and New Jersey after potential quality issues were discovered in their manufacturing.

“Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks,” the Swiss company said.

The drugmaker added in a statement that some doses of cancer therapy Lutathera would be available in Europe and Asia from a site in Spain, but there might be some delays in supply.

Lutathera and Pluvicto are both so-called radioligand therapies. The U.S. Food and Drug Administration approved Pluvicto in March for treatment of prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC).

Lutathera was approved in 2018 to treat somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Reuters Health Information © 2022

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