Novartis suspends production of 2 cancer treatments over quality concerns

Novartis is temporarily suspending production of Lutathera and Pluvicto over "potential quality issues identified in its manufacturing processes," it said May 5. 

Three notes: 

1. The company did not specify what the quality issues were and said it is conducting a review of the situation. It expects to resume production in the next six weeks. 

2. Novartis is temporarily suspending the delivery of Lutathera — used to treat adults with gastroenteropancreatic neuroendocrine tumors that are positive for the hormone receptor somatostatin — in the U.S. and Canada. Pulvicto — approved for treatment of prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer — deliveries are suspended in the U.S. The suspensions also apply to clinical trial enrollments.  

3. There is currently no indication of any risks to patients who have received doses previously produced at the New Jersey and Italy facilities where production was paused, Novartis said. It has notified treatment sites to closely monitor patients who have recently gotten injections of the treatments. 

"We recognize that this situation affects patients, their families and care teams," the company said. "Novartis takes this very seriously, and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible. Health authorities have been informed and will receive additional updates as they are available."

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars