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|Project Number||pCODR 10142|
|Generic Name||Lutetium Lu 177 dotatate|
|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.