Curium™ announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate for adults with SSTR-positive GEP-NETs
Update 15th September 2026 The FDA has approved lutetium Lu 177 dotatate injection (Bexlutry) for the treatment of adult patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. BEXLUTRY™ is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA® (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy. Click here to read the news from Curium. Update 1st July 2026. This approval was being held up by legal processes after a patent dispute brought by…