The US Food and Drug Administration on Friday approved 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).
The FDA granted the approval of Lutathera to France-based Advanced Accelerator Applications (AAA), which has been acquired by Swiss pharma giant Novartis (NOVN: VX) in a $3.9 billion deal that closed just a few days ago.
This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs in the USA. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.
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