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Pharmaceuticals / Submissions and Approvals

FDA Approves Lutathera As First Radioactive GEP-NETs Treatment

Jan. 30, 2018

The FDA approved Novartis’ radioactive drug Lutathera for the treatment of a type of cancer that impacts the pancreas or gastrointestinal tract.

The drug attacks gastroenteropancreatic neuroendocrine tumors (GEP-NETs) by attaching to a cell present in certain tumors and using radiation to damage to the tumor cells. The agency’s acceptance marks the first approval of a radioactive drug product for the treatment of GEP-NETs.

The agency had granted Lutathera (lutetium Lu 177 dotatate) priority review. It was also granted orphan drug designation.

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