177Lu-Oxodotreotide (177Lu-Lutathera®, 177Lu-DOTATATE) is a radiolabeled somatostatin analogue developed for the treatment of neuroendocrine tumors (NET). The drug was launched in January 2018.
This radiolabeled drug has been under clinical evaluation for the past 15 years at the Erasmus MC (Rotterdam, The Netherland). Other clinical investigations have been carried out at Uppsala Sweden, Milano (Italy) and Fremantle Australia, and more recently at Bad Berka, Germany, and Basel, Switzerland. In the US, the Excel Diagnostics Nuclear Oncology Center in Houston TX was the first research facility in North America to obtain authorization to treat patients with 177Lu-DOTATATE.
177Lu-DOTATATE has been developed for treatment of patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET). Phase II results (Erasmus MC, Rotterdam) in progressive midgut carcinoid showed progression-free survival of more than 45.1 months compared to the reported 14.6 months of Novartis’ Sandostatin® LAR®.
FDA allowed an amendment to the protocol for the US Expanded Access Program (EAP) for Lutathera® expanding access to patients with progressive, advanced, inoperable NETs arising at all sites. Actually 177Lu-Lutathera could be efficient for most of the GEP-NET indications but further clinical exploration is needed and studies are presently under way.
Non-NET indications in which 177Lu-Oxodotreotide is explored include: medullary thyroid cancer (initiated 2013) , carcinoid heart disease (2019) , metastatic Merkel cell carcinoma (2020, in combination with avelumab), meningioma (2019), pheochromocytoma and ganglioma (2017), neuroblastoma (2019) and SCLC (2017).