Regulatory Event: USFDA New Drug Approval
Approval Date: 14 September 2026
Applicant: Curium US LLC
NDA: 218525
Intelligence Overview
The U.S. Food and Drug Administration (USFDA) has approved Bexlutry® (lutetium Lu 177 dotatate) injection, developed by Curium US LLC, under NDA 218525.
The approval covers the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
The product is supplied at 370 MBq/mL (10 mCi/mL), with an expiry dating period of 72 hours from the time of calibration when stored at controlled room temperature.
Why it matters: This approval adds another FDA-approved radiopharmaceutical option for the treatment of somatostatin receptor-positive GEP-NETs.
Reference: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218525Orig1s000ltr.pdf