FDA clears Curium’s BEXLUTRY, a Lutathera-equivalent radioligand therapy

Curium said the FDA approved BEXLUTRY (lutetium Lu 177 dotatate injection) on September 14, 2026, for adults with somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), spanning foregut, midgut and hindgut tumors.

The company describes BEXLUTRY as the first “radioligand equivalent” for this use. It was cleared via the FDA’s 505(b)(2) pathway, using published evidence and bridging data rather than as a conventional FDA-designated generic or biosimilar.

BEXLUTRY has the same active radiopharmaceutical ingredient as Novartis/Advanced Accelerator Applications’ Lutathera:
lutetium Lu 177 dotatate. Lutathera was first approved for adult SSTR-positive GEP-NETs in 2018.

Curium’s entry followed patent litigation with Novartis subsidiary Advanced Accelerator Applications. A June 2026 court ruling invalidated asserted patent claims under the on-sale bar, reducing a key obstacle to Curium’s launch.

The approval is adult-only, whereas Lutathera’s current U.S. label also covers pediatric patients aged 12 and older. Commercial availability, pricing, reimbursement and treatment-center capacity will determine whether it meaningfully expands patient access or lowers treatment costs.