Bexlutry cleared for somatostatin receptor-positive GEP-NETs

What this means

Neuroendocrine tumors that arise in the gut and pancreas often display high levels of a cell-surface protein called the somatostatin receptor. Bexlutry (lutetium Lu 177 dotatate) is a radioligand therapy that pairs a molecule which binds those receptors with a small dose of radioactive lutetium-177; once bound to the tumor cells, the radiation destroys them from within. FDA approved it on Sept 14, 2026 for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) — including foregut, midgut, and hindgut origins. Bexlutry was approved under the 505(b)(2) regulatory pathway as a radioligand equivalent of Novartis's Lutathera (approved 2018), supported by published Lutathera evidence and targeted bridging data. It is Curium's first FDA-approved radioligand therapy and is expected to expand access to targeted radiotherapy for GEP-NETs.