May 5, 2022
On May 5, Novartis announced that it will suspend production of Lutathera and Pluvicto at its radioligand therapy production sites in Ivrea, Italy, and Milburn, New Jersey, affecting both commercial and clinical trial supply. The voluntary shutdown is a response to potential quality issues, “out of an abundance of caution,” Novartis said. The company expects that the issues will be resolved within six weeks, at which point production will gradually resume.
One of the drugs, Pluvicto, was approved by the U.S. Food and Drug Administration (FDA) on March 23 to treat metastatic castration-resistant prostate cancer (mCRPC). The therapy, developed after years of extensive research, was shown to reduce the risk of death by 38 percent and reduce the risk of progression by 60 percent in mCRPC patients.
The other drug, Lutathera, was approved by the FDA in early 2018 for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Novartis hopes to have an update within the next 2-4 weeks.
SNMMI and the patients we serve will need a reliable supply chain for innovative radiopharmaceutical therapies to be used regularly and widely. SNMMI looks forward to further updates and to helping contribute in the radiopharmaceutical therapy space.
Additional information will be posted here as it becomes available.