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Lutathera for Gastroenteropancreatic neuroendocrine tumors – Details

Project Number pCODR 10142
Brand Name Lutathera
Generic Name Lutetium Lu 177 dotatate
Tumour Type Gastrointestinal
Indication Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Funding Request For the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults whose disease has progressed and is unresectable.
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Advanced Accelerator Applications
Submitter Advanced Accelerator Applications
Submission Date July 30, 2018
Submission Deemed Complete August 7, 2018
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ August 14, 2018
Check-point meeting October 10, 2018
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.