AAA gains European approval for Lutathera

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.

The news caused the shares of the drug’s developer, France’s Advanced Accelerator Applications (Nasdaq: AAAP [AAA]) to rise 3.87% to $67.62 on Friday. 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: "This is a historic moment. We are proud to bring this first-in-class drug, and the very first registered Peptide Receptor Radionuclide Therapy (PRRT), to the European NET patient community. We will continue to work closely with the respective health authorities to make lutetium (177Lu) oxodotreotide (Lutathera) widely available. We believe numerous clinical studies in the nuclear medicine field have demonstrated the advantages of selectively delivering radiation to tumor cells over certain other therapies, and we are committed to advancing this approach to cancer treatment.