Advanced Accelerator Applications S.A. (NASDAQ:AAAP) announced that the European Commission has authorized the marketing of its drug, Lutathera (lutetium oxodotreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET) in adult patients. The approval allows the company to market the drug in Iceland, Norway and Liechtenstein along with 28 European Union countries.
The drug is under review in the United States. A decision is expected in January 2018.
Shares of the company were up almost 3.9% following the news on Friday. In fact, Advanced Accelerator Applications’ stock is up 152.7% so far this year, significantly outperforming the industry’s gain of 3.7% in that period.
The approval of the marketing authorization was based on data from a phase III study – NETTER-1 – which showed that Lutathera reduced progression free survival by 79% compared to octreotide LAR in patients with unresectable or metastatic, progressive, somatostatin receptor positive GEP-NET. Although the targeted overall survival (OS) data is yet to be reached, the current data showed 46% reduction in risk of death for Lutathera compared to octreotide.
The marketing authorization application also included efficacy and safety data from a Phase I/II study conducted by Erasmus Medical Center.
Per the European Society for Medical Oncology, GEP-NET occurs in 5.25 persons in a population of 100,000 every year.
The company markets SomaKit TOC in Europe and NETSPOT in the United States in GEP-NET patients for diagnostic purpose. It recorded revenues of €69.2 million in the first six months of 2017, an increase of 27% from the year-ago period.
Lutathera, a peptide receptor radionuclide therapy, is the company’s first drug approved as a therapeutic drug for GEP-NET.
However, Advanced Accelerator Applications recognizes three other radiopharmaceutical products already available in the market. These include Bayer AG’s (OTC:BAYRY) Xofigo for prostate cancer, Zevalin from Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) and GlaxoSmithKline plc’s (NYSE:GSK) Bexxar for non-Hodgkin’s lymphoma.
Advanced Accelerator Applications currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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