The FDA has approved Curium's Bexlutry, the first generic radioligand therapy, targeting neuroendocrine tumors and referencing Novartis' Lutathera. The approval follows a June 2026 patent victory for Curium against Novartis. While Novartis relies on its robust supply chain to withstand generic competition, Curium is expanding into therapeutics and is acquiring rival Lantheus for up to $8 billion.
Bexlutry FDA approval
- ▪The FDA approved Curium's Bexlutry (lutetium Lu 177 dotatate injection), the industry's first generic radioligand therapy, on September 14, 2026.
- ▪Curium's Bexlutry is indicated for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and targets the somatostatin receptor to deliver a radioactive payload.
505(b)(2) regulatory pathway
- ▪Curium's Bexlutry received FDA approval through the 505(b)(2) pathway, which is a hybrid new drug application process.
- ▪The FDA's 505(b)(2) regulatory pathway allows drug developers to rely on existing data from previously approved reference drugs.
Patent litigation victory
- ▪A court decision in June 2026 cleared Curium of all patent infringement claims brought by Novartis, enabling the FDA's subsequent approval of Bexlutry.
- ▪Curium filed for FDA approval of Bexlutry in July 2024.
Curium therapeutic expansion
- ▪The approval of Bexlutry marks Curium's expansion beyond its traditional diagnostic imaging business and into therapeutics.
- ▪Curium's existing diagnostic portfolio includes Detectnet, an imaging agent that helps locate somatostatin receptor-positive neuroendocrine tumors.
Novartis competitive positioning
- ▪Novartis CEO Vas Narasimhan stated in July 2026 that Novartis has mitigated the impact of generic competition through its extensive supply and delivery network.
- ▪Novartis' Lutathera, which was approved in January 2018 as the first radioligand therapy, generated $436 million in sales in the first half of 2026.
Lantheus acquisition
- ▪Lantheus received tentative FDA approval in March 2026 for its Lutathera generic, PNT2003, under the abbreviated new drug application pathway.
- ▪Curium is in the process of acquiring its radiopharma rival Lantheus for up to $8 billion.
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