FDA approves new generic radiopharmaceutical alternative from Curium
The U.S. Food and Drug Administration has approved a new generic radiopharmaceutical alternative from drugmaker Curium, aimed at competing with another treatment on the market.
Bexlutry (lutetium Lu 177 dotatate) is a radioligand therapy designed to deliver targeted radiation for treating a group of rare cancers originating in the digestive track and pancreas. Boston-based Curium scored the approval through the FDA’s 505(b)(2) pathway, supported by published evidence and targeted bridging data.
This demonstrated that Bexlutry achieved a similar biological and chemical profile to the previously approved Lutathera, manufactured by rival firm Novartis.
“Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer,” Mike Patterson, Curium’s CEO of North America, said in a statement Sept. 14. “Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”
Bexlutry delivers targeted radiation to receptor-positive gastroenteropancreatic neuroendocrine tumors via an injection. Like Lutathera, it works by binding to somatostatin receptors frequently expressed on tumors. Approved in 2018, Novartis previously reported approximately $436 million in Lutathera sales in the first half of 2026, Seeking Alpha reports.
Drugmaker Lantheus also earned tentative FDA approval for its own equivalent to the drug in March. Following that news, Curium in August announced it had inked a definitive deal to acquire Lantheus for up to $8 billion.
Curium won approval for the new generic after a tough legal battle, Fierce Pharma notes. The drugmaker first filed for approval in July 2024 and the FDA only moved forward after a court decision in June cleared Curium of patent-infringement claims brought by Novartis.
“FDA approval of Bexlutry is a defining milestone for Curium as we expand our offering into oncology therapeutics,” added Renaud Dehareng, Curium’s group CEO. “With over 100 years of experience in nuclear medicine and a long-standing commitment to the [neuroendocrine tumor] community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.