Regulatory & Policy

FDA approves Curium’s Bexlutry, challenging Novartis’ Lutathera monopoly in GEP-NETs

Edited by Robert McTiernan··2 min read
FDA approves Curium’s Bexlutry, challenging Novartis’ Lutathera monopoly in GEP-NETs

The US FDA has approved Bexlutry (lutetium Lu 177 dotatate), a radioligand therapy from Boston-based Curium, for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. The approval, granted via the 505(b)(2) pathway, marks Curium's entry into oncology therapeutics and introduces a competitor to Novartis's Lutathera (lutetium Lu 177 dotatate), which has held the only approved lutetium dotatate product in this indication since 2018.

Bexlutry was approved as a radioligand equivalent to Lutathera, supported by published evidence and targeted bridging data that Curium said demonstrated a similar biological and chemical profile to the reference product. The therapy is administered intravenously at a recommended cumulative dose of 29.6 GBq, with co-administration of an amino acid solution required before, during, and after each dose to reduce renal radiation exposure.

The clinical evidence cited in Bexlutry's labeling draws on two studies conducted with lutetium Lu 177 dotatate: the Phase III NETTER-1 trial, which evaluated the agent in patients with midgut NETs and demonstrated progression-free survival benefit versus high-dose long-acting octreotide, and the ERASMUS expanded access study, which provided long-term safety data across a broader GEP-NET population. No separate pivotal trial was conducted for Bexlutry itself; the 505(b)(2) pathway allowed reliance on the established evidence base for the reference product.

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Bexlutry binds to somatostatin receptors overexpressed on GEP-NET cells, delivering targeted beta-particle radiation directly to tumor tissue. The mechanism is identical to that of Lutathera, with the 505(b)(2) approval resting on Curium's demonstration of comparable physicochemical and biological properties rather than independent clinical efficacy data.

The approval follows Curium's June 2026 patent litigation victory over Novartis subsidiary Advanced Accelerator Applications, in which a Delaware federal court ruled all relevant patent claims invalid and not infringed. That ruling cleared the regulatory and commercial path for Bexlutry's launch. Curium said the product is immediately available for prescribing. Curium has also agreed to merge with Lantheus in a transaction valued at up to approximately USD 8 billion, potentially further expanding the combined company’s radiopharmaceutical development, manufacturing, and distribution capabilities.

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