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Advanced Accelerator Applications Announces Positive CHMP Opinion Recommending Approval of Lutetium 177Lu Oxodotreotide (Lutathera®) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors

SAINT-GENIS-POUILLY, France, July 21, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending 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 European Commission (EC), which has the authority to approve medicines for the European Union, Iceland, Norway and Liechtenstein will review the CHMP recommendation.

Gastroenteropancreatic neuroendocrine tumors, also known as GEP-NETs, are a group of tumors originating in the neuroendocrine cells of numerous organs. According to the European Society for Medical Oncology (ESMO), the crude incidence of GEP-NETs is estimated to be 5.25/100,000 per year.1 Lutetium (177Lu) oxodotreotide (Lutathera®) has received orphan drug designation from the EMA.

Stefano Buono, Chief Executive Officer of AAA, commented, “We are proud to achieve this important milestone. Peptide Receptor Radionuclide Therapy (PRRT) has been included in both the ESMO and European Neuroendocrine Tumor Society (ENETS) guidelines as a treatment option for certain NET indications since 2012, and now lutetium (177Lu) oxodotreotide (Lutathera®) is the very first PRRT to have achieved a positive CHMP opinion. We look forward to collaborating with the European health authorities to make lutetium (177Lu) oxodotreotide (Lutathera®) widely available as soon as possible. To date, more than 1,700 NET patients across 10 European countries have already received the treatment under compassionate use and named patient programs.”

The CHMP adopted its opinion based on results of a randomized pivotal Phase 3 study, NETTER-1 that compared treatment using lutetium (177Lu) oxodotreotide with a double dose of Octreotide LAR in 229 patients with inoperable midgut NETs progressive under standard Octreotide LAR treatment and overexpressing somatostatin receptors, as well as efficacy and safety data from the Erasmus Phase 1/2 trial conducted in more than 1,200 patients with a wide range of NET indications including bronchial, pancreatic, foregut (excluding bronchial and pancreatic), midgut and hindgut.

The NETTER-1 study met its primary endpoint by demonstrating that treatment with lutetium (177Lu) oxodotreotide was associated with a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death versus a treatment with a double dose of Octreotide LAR (hazard ratio 0.21, 95% CI: 0.13-0.33; p<0.001).2 Lutetium (177Lu) oxodotreotide, when administered concomitantly with a renal-protective agent, had low rates of grade three or four hematological toxicity, and no evidence of nephrotoxicity observed over the study time-frame (median follow-up time 14...