US regulators have cleared the use of Advanced Accelerator Applications’ Lutathera to treat certain gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The decision allows the therapy’s use in (GEP-NETs) - including foregut, midgut, and hindgut neuroendocrine tumors - that are somatostatin receptor positive
Lutathera (lutetium Lu 177 dotatate) is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of treatment comprising of a targeting molecule that carries a radioactive component.
Approval came after Phase III data showed a 79 percent reduction in the risk of disease progression or death within the Lutathera plus best standard of care arm versus 60mg of octreotide LAR alone.
Advanced Accelerator Applications is now a subsidiary of Novartis Groupe SA, following a $3.9 billion cash deal last October.