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Advanced Accelerator gets Approval for Gastrointestinal Cancer Drug

First radioactive drug to be approved for gastroenteropancreatic neuroendocrine tumors.

Advanced Accelerator Applications (Nasdaq: AAAP), the French radiopharmaceutical and diagnostic products company whose acquisition by Novartis (NYSE: NVS) is through the tender process as of this week, received FDA approval today for Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs and has previously received approval to be marketed in all EU countries, Norway, Iceland and Liechtenstein.

GEP-NETs can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately one out of 27,000 people are diagnosed with GEP-NETs per year.

Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

The approval of Lutathera marks an important achievement and innovation for the NET community. As the first Peptide Receptor Radionuclide Therapy (PRRT) ever approved in the US, Lutathera is introducing a major advancement in the treatment paradigm for these patients that we hope will improve many lives. We believe nuclear medicine has the potential to offer many benefits to cancer patients and will use this approval as a foundation for the development of additional targeted cancer treatments utilizing radiolabeled ligands.

– Susanne Schaffert, PhD, Chairperson and President of Advanced Accelerator Applications.

GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing. This approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment.

– Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

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