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Lutathera Approval Status

  • FDA approved: No
  • Brand name: Lutathera
  • Generic name: lutetium Lu 177 dotatate
  • Company: Advanced Accelerator Applications S.A.
  • Treatment for: Neuroendocrine Carcinoma

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide in development for the treatment of gastroenteropancreatic neuroendocrine tumors.

In December 2016, Advanced Accelerator Applications S.A. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors. The CRL referred to issues relating to the NETTER-1 and Erasmus clinical datasets, and a safety update on clinical and non-clinical studies was also requested.

Development Status and FDA Approval Process for Lutathera

DateArticle
Dec 21, 2016Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera, an Investigational Treatment for Neuroendocrine Tumors
Jun 27, 2016Advanced Accelerator Applications Announces FDA Priority Review for Lutathera
Oct 22, 2013AAA Reaches Halfway Recruitment Milestone of Cancer Patients in Lutathera Trial

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