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US Food and Drug Administration approves Advanced Accelerator Applications' Lutathera cancer drug.

M2 EQUITYBITES-January 30, 2018-US Food and Drug Administration approves Advanced Accelerator Applications' Lutathera cancer drug

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The US Food and Drug Administration (FDA) has approved France-based Advanced Accelerator Applications' radioactive drug, Lutathera (lutetium Lu 177 dotatate), intended for the treatment of gastroenteropancreatic neuroendocrine tumours, it was reported yesterday.

The approval is for adult patients with somatostatin receptor-positive GEP-NETs and it includes conditions such as foregut, midgut, and hindgut neuroendocrine tumours.

The product received approval based on the findings of a phase three trial named NETTER-1 and also by a subset of efficacy and safety data from a single-arm, open-label trial in The Netherlands in more than 1,200 patients with somatostatin receptor positive tumours. In NETTER-1, the drug had decreased the risk of disease progression or death by 79% in combination with best standard of care arm (octreotide LAR 30mg every four weeks).

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Publication:M2 EquityBites (EQB)
Date:Jan 30, 2018
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