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Lutathera Clinical Development Timeline

Executive Summary

Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.

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Lutathera Reviewers

US FDA staff who participated in the review and approval of AAA's treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Giapreza Reviewers

US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.

Lutathera’s Broad Tumor Indication Aided By Expanded Access Data

US FDA’s approval of Advanced Accelerator Applications’ radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors was driven by robust Phase III study results in midgut carcinoid tumors and data from an investigator-initiated, expanded access study in the Netherlands that enrolled patients with a host of other neuroendocrine tumor types.

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