Novartis is hitting the brakes on manufacturing its two marketed radioligand therapies for cancer treatment mere weeks after trumpeting an FDA approval.
Novartis has temporarily stopped producing its neuroendocrine tumor therapy Lutathera as well as its freshly FDA-approved prostate cancer drug Pluvicto at facilities in Ivrea, Italy, and Millburn, New Jersey, the Swiss pharma said Thursday.
The company is taking the dramatic action “out of an abundance of caution as a result of potential quality issues identified in its manufacturing processes,” it said. A Novartis spokesperson declined to offer additional details on the nature of the problem.
Thanks to the abrupt manufacturing mishap, Novartis has stopped delivering Lutathera to customers in the U.S. and Canada, and Pluvicto in the U.S. The surprising supply suspension comes merely six weeks after Pluvicto received an FDA approval in previously treated, PSMA-positive, metastatic castration-resistant prostate cancer.
Enrollment for clinical trials of Pluvicto has stopped globally, and so have Lutathera's clinical studies in the U.S. and Canada.
Novartis said there’s currently no sign of any risk to patients who received doses it had already delivered at those sites. Still, it’s asking designated radioligand therapy treatment centers to “closely monitor patients who have recently been injected” and to report any side effects.
Regulators have been informed, and Novartis is conducting a review. As for the timeline for production resumption, Novartis said it expects to resolve the issues and “resume some supply” in the next six weeks.
“We recognize that this situation affects patients, their families and care teams,” Novartis said in a statement. “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.”
In the meantime, one Novartis radioligand therapy production site in Zaragoza, Spain, remains operational and is making Lutathera for Europe and Asia, although Novartis warns of possible delays in supply.
Both Lutathera and Pluvicto are radioligand therapies, an area CEO Vas Narasimhan has labeled as one of the Swiss pharma’s key advanced technology platforms alongside RNA medicines and cell and gene therapies.
According to Novartis, radioligand therapies combine therapeutic radioactive isotopes with cell-targeting compounds, or ligands. The radioisotopes are produced in special nuclear reactors and then coupled with the ligand at a production facility. The finished product is packaged into special lead-shielded containers and shipped directly to treatment sites.
This isn’t the first time Novartis has stumbled over manufacturing of an advanced therapy. During the early launch of CAR-T cell therapy Kymriah in blood cancers, the company had struggled with keeping the final product within commercial specifications. That initial hiccup, to some extent, hurt early physician confidence in Kymriah in favor of Gilead Sciences’ rival CAR-T drug, Yescarta.