Novartis has taken steps to resolve quality issues that halted production of its Lu-177 DOTATATE (Lutathera) and Lu-177-PSMA-617 (Pluvicto) radiopharmaceutical cancer therapies, yet the dip in supply is still affecting patients, their families, and care teams, the company said in a June 30 news release.
"We expect that product supply may be initially limited, and we are working hard to resume full production capacity and meet patient demand as quickly as possible," the company said.
In May, Novartis announced it had temporarily suspended supply of its two therapeutic radiopharmaceuticals due to "quality issues identified in its manufacturing processes," and said a resolution was expected within six weeks.
Ahead of that timeline, the company has restarted radioligand therapy production at its sites in Ivrea, Italy, and Millburn, NJ, and resumed delivery of doses to patients in a phased approach.
In addition, Novartis said it has also restarted screening and enrollment for clinical trials with Pluvicto in the U.S., in most countries globally, and clinical trials with Lutathera in the U.S. and Canada.
The company said it has remediated the issues that led to the temporary suspension of production and noted the issues did not affect patient safety. What's more, there was no risk to patients from doses previously produced.
