The European Commission has approved the marketing authorization of Lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
This approval allows for the marketing of lutetium (177Lu) oxodotreotide (Lutathera®) in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein.
Stefano Buono, chief executive of AAA, commented: ”NET patients who have had tumors successfully localized using PET scans with our SomaKit TOC diagnostic drug approved in Europe, may also be candidates for therapy with lutetium (177Lu) oxodotreotide (Lutathera), since the drugs bind to the same receptor. This theragnostic pairing for NETs is one of three drugs in our oncology pipeline, through which we are leveraging the same targeting molecule to license two separate products. Our next pairings in development target malignancies such as prostate and breast cancers and gastrointestinal stromal tumors.”