Lutathera Clinical Development Timeline
Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.
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US FDA staff who participated in the review and approval of AAA's treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
After publication of ATHOS-3 study results, agency received several requests from medical community for emergency use in hospitalized patients with shock and hypotension unresponsive to available therapy, spurring FDA to take an approval action two months ahead of user fee goal date.
US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.