Due to manufacturing issues, Novartis has voluntarily suspended production of two therapies that use nuclear medicine to target and treat cancer cells, and also halted clinical trials for one of the treatments, which was approved in the U.S. only two months ago.
The company hit the pause button on Lutathera, which is used to treat neuroendocrine tumors and has been available since 2018. The other medication is Pluvicto, a prostate cancer drug that was recently endorsed by the U.S. Food and Drug Administration for treating a form of advanced cancer, although Novartis has high hopes it can eventually be used for combating earlier stages of the disease.
In a brief statement, the company explained it took this step “out of an abundance of caution as it address potential quality issues identified in its manufacturing processes.” The drugmaker, which makes the medicines at facilities in New Jersey and Italy, expects to resolve the issues and resume some supplies in the next six weeks.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.