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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 Notification to Implement Issued
Pre Noc Submission Yes
NOC Date January 9, 2019
Manufacturer Advanced Accelerator Applications
Sponsor 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 May 31, 2019
Feedback Deadline ‡ June 14, 2019
pERC Reconsideration Meeting July 18, 2019
Final Recommendation Issued August 1, 2019
Notification to Implement Issued August 19, 2019

‡ 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.