Novartis has temporarily suspended supply of its two therapeutic radiopharmaceuticals based on lutetium-177 (Lu-177) ligands due to "quality issues identified in its manufacturing processes," the company said in a May 5 statement.
The production suspension affects commercial and clinical trial supply of Lu-177 DOTATATE (Lutathera) for patients with neuroendocrine tumors and Lu-177-PSMA-617 (Pluvicto) for patients with metastatic prostate cancer.
A resolution is expected within six weeks, Novartis said.
The announcement was a stumble out of the gate for Pluvicto, which received approval from the U.S. Food and Drug Administration (FDA) on March 23. Lutathera was approved by the FDA in January 2018.
Some doses of Lutathera will be available in Europe and Asia from a radioligand therapy production site in Zaragoza, Spain, Novartis said. In addition, Novartis is putting a temporary hold on screening and enrollment for Pluvicto clinical trials globally, and Lutathera clinical trials in the U.S. and Canada.
"There is currently no indication of any risk to patients from doses previously produced at these sites," Novartis said.
However, the company has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety, according to the statement.
Health authorities have been informed and will receive additional updates as they are available, Novartis said. Representatives for Novartis and Lu-177 supplier ITM Isotope Technologies Munich declined to offer additional details.
