September 29, 2017

Advanced Accelerator Applications Announces European Approval of Lutetium (177Lu) Oxodotreotide (Lutathera®) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors – Completes First Theragnostic Radiopharmaceutical Pairing in Oncology

AAA today announced that the European Commission (EC) 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.

September 6, 2017

Advanced Accelerator Applications Announces First Patient in Bridging Study in Japan for Lutetium Lu 177 Dotatate (Lutathera®)

AAA today announced that the first patient has been treated in a Phase I clinical study of lutetium Lu 177 dotatate* in patients with inoperable, somatostatin receptor positive, progressive pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors (NETs) in Japan. The primary objective of this open-label, uncontrolled, single-center, bridging study is to evaluate the safety, tolerability, pharmacokinetics, and dosimetry of lutetium Lu 177 dotatate in Japanese patients. Six subjects will be included in the Phase I study.