Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA), an international specialist in Molecular Nuclear Medicine (MNM), announced that the European Commission (EC) has approved the marketing authorisation of Lutathera® (lutetium (177Lu) oxodotreotide) for “the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.”
This approval allows for the marketing of Lutathera® in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein.
Stefano Buono, Chief Executive Officer of AAA, commented: “This is a historic moment for the company. 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 in each country to make Lutathera® widely available. Numerous clinical studies in the nuclear medicine field have demonstrated the advantages of selectively delivering radiation to tumour cells over certain other therapies, and we are committed to advancing this approach to cancer treatment. “
“With this approval, AAA has become the first theragnostic radiopharmaceutical company in the oncology market. We believe our platform, which involves radiolabeling a single targeting molecule with either gallium Ga 68 for diagnostic use or lutetium Lu 177 for therapeutic use will deliver improved patient outcomes”, Buono added.
Martyn Caplin, Professor of gastroenterology and GI neuroendocrinology at the Royal Free London and University College London and Vice Chair (former Chairman) of the European Neuroendocrine Tumor Society, stated: “There are very few effective treatment options for patients with inoperable, advanced GEP-NETs who are progressive on somatostatin analogues. Having this therapy approved and available will offer physicians a further option to help manage their patients’ disease.”