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Lutathera FDA 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 Timeline 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

Further information

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