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Lutathera for Gastroenteropancreatic neuroendocrine tumors – Details

Project Number pCODR 10142
Brand Name Lutathera
Generic Name Lutetium Lu 177 dotatate
Strength 370 MBq/mL
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 January 9, 2019
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 May 16, 2019
Initial Recommendation Issued (target date) May 31, 2019
Feedback Deadline (target date) ‡ June 14, 2019
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued
Clarification The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided.

‡ 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.