177Lu-Edotreotide (177Lu–Octreotide, 177Lu-Solucin®) is a radiolabeled somatostatin analogue developed for the treatment of NET. It is derived from the equivalent 90Y-Edotreotide originally developed under the name Onalta®.
177Lu-Edotreotide obtained the Orphan Drug designation from the EMA in July 2014 and from the FDA in June 2015 for the indication P-NET (pancreatic neuroendocrine tumors).
177Lu-Edotreotide will be developed for the treatment of patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET). This molecule must be considered as the first competitor for the analogue 177Lu-Octreotate (177Lu-Lutathera®).
A Phase III trial involving 300 patients was initiated in February 2017. This study is supposed to be completed by 2021. Another Phase III trial (COMPOSE) was initiated in September 2021.
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