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.
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).
This drug is also available in Iran under the name PARS-Lutodotatate.
Non-carrier-added 177Lu labeled oxodotreotide is under development by the company Point Biopharma under the name 177Lu-PNT2003. It is a full analogue of Lutathera, which is completing Phase III trial. This new form may reach the market by end of 2022. Indications for 177Lu-PNT2003 (non GEP-NET and new GEP indications) is not supposed to overlap indications for Lutathera (mid-gut GEP-NET).
Target/Mechanism: Somatostatin receptors
Radiation Type: beta electrons (β–)