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Lutathera Approval History

  • FDA approved: Yes (First approved January 26, 2018)
  • Brand name: Lutathera
  • Generic name: lutetium Lu 177 dotatate
  • Dosage form: Injection
  • Company: Advanced Accelerator Applications S.A.
  • Treatment for: Gastroenteropancreatic Neuroendocrine Tumors

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Development History and FDA Approval Process for Lutathera

DateArticle
Jan 26, 2018Approval FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors
Aug 28, 2017Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) date of January 26, 2018, for Lutetium Lu 177 Dotatate (Lutathera)
Jul 27, 2017Advanced Accelerator Applications Completes Resubmission of NDA for Lutetium Lu 177 Dotatate (Lutathera) to FDA
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

Further information

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