Skip to Content

Lutathera Approval History

  • FDA approved: Yes (First approved January 26th, 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

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.