{"entity":{"id":"lu-177-dotatate-generic","kind":"drug","name":"Lutetium-177 dotatate (radioligand equivalent)","aka":["Bexlutry","generic lutetium Lu 177 dotatate"],"tldr":"A second, cheaper version of an already-approved radioactive drug for neuroendocrine tumours has been approved, using the same active radioactive ingredient as the original but made by a different company.","summary":"Bexlutry (lutetium Lu 177 dotatate injection), from Curium, is the first product the FDA has approved as a 'radioligand equivalent' of an existing radiopharmaceutical: it has the same active radiopharmaceutical ingredient as Novartis/Advanced Accelerator Applications' Lutathera. The FDA approved it on 14 September 2026 for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), spanning foregut, midgut and hindgut tumours.\n\nCurium filed under the FDA's 505(b)(2) pathway in July 2024, relying on published evidence and bridging data demonstrating a similar biological and chemical profile to Lutathera rather than running a new phase 3 trial. Approval followed a June 2026 court decision that cleared Curium of patent-infringement claims brought by Novartis. Unlike Lutathera, whose US label also covers paediatric patients aged 12 and older, Bexlutry's approval is adult-only.\n\nBexlutry is immediately available for prescribing in the US. A second lutetium dotatate candidate, Lantheus's PNT2003, received FDA tentative approval in March 2026 under the abbreviated new drug application (ANDA) pathway but is not yet launched; separately, ITM's related product 177Lu-edotreotide (ITM-11) received an FDA complete response letter in August 2026 over manufacturing and third-party facility issues unrelated to its clinical data. Bexlutry's approval is the first time a radioligand therapy for cancer has faced this kind of direct, lower-cost competition in the US market.","status":"approved","asOf":"2026-09-27","links":[{"label":"Drugs@FDA: NDA 218525, Bexlutry (lutetium Lu 177 dotatate)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218525"},{"label":"Curium: FDA approval of BEXLUTRY, 14 September 2026","url":"https://www.curiumpharma.com/2026/09/14/fda-approval-bexlutry/"},{"label":"FiercePharma: FDA approves first radioligand equivalent","url":"https://www.fiercepharma.com/pharma/fda-approves-first-radioligand-equivalent-curiums-copycat-novartis-lutathera"},{"label":"MedPath: FDA approves Curium's Bexlutry, first generic radioligand","url":"https://trial.medpath.com/news/fda-approves-curium-s-bexlutry-first-generic-radioligand-challenging-lutathera-s-gep-net-monopoly"}],"tags":["radioligand therapy","generic","neuroendocrine tumours","beta emitter"],"related":["lutathera","itm-11","lu-177"],"indications":["neuroendocrine","pancreatic-net","small-intestinal-net"],"sections":[],"technologies":["radioligand-therapy","prrt"],"targets":["sstr2"],"drugs":[],"companies":["curium"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Bexlutry","modality":"radioligand therapy","mechanism":"A somatostatin analogue (DOTATATE) labelled with beta-emitting lutetium-177, delivering targeted radiation to somatostatin receptor-positive neuroendocrine tumour cells; chemically and biologically the same active ingredient as Lutathera, approved through the FDA's 505(b)(2) route as a radioligand equivalent rather than through a new pivotal efficacy trial.","approvals":[{"region":"US","year":2026,"indication":"Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut and hindgut tumours, in adults","note":"Approved via the FDA 505(b)(2) pathway as a radioligand equivalent of Lutathera, 14 September 2026"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-09-14","type":"approval","region":"US","note":"Bexlutry, NDA 218525 (Curium), original approval; FDA classification Type 5 new formulation or new manufacturer, standard review","source":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218525"}]},"route":"/drugs/lu-177-dotatate-generic/","neighbours":{"drug":[{"id":"itm-11","kind":"drug","name":"177Lu-edotreotide","route":"/drugs/itm-11/"},{"id":"lutathera","kind":"drug","name":"Lutetium-177 dotatate","route":"/drugs/lutathera/"}],"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"neuroendocrine","kind":"indication","name":"Neuroendocrine tumours","route":"/indications/neuroendocrine/"},{"id":"pancreatic-net","kind":"indication","name":"Pancreatic neuroendocrine tumours","route":"/indications/pancreatic-net/"},{"id":"small-intestinal-net","kind":"indication","name":"Small intestinal neuroendocrine tumours","route":"/indications/small-intestinal-net/"}],"technology":[{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"company":[{"id":"curium","kind":"company","name":"Curium","route":"/companies/curium/"}]}}