Treats somatostatin receptor-positive … hindgut neuroendocrine tumors. NDA 218525, held by Curium. Lutetium Lu-177 Dotatate.
As of Nov 13, 2026, NDA 218525 (Bexlutry), held by Curium, was first approved by FDA on Sep 14, 2026, with 0 approved supplements and 0 published complete response letters.
BEXLUTRY is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bexlutry10mCi/ML · solution;intravenous | Lutetium Lu-177 Dotatate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
