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Afinitor for pancreatic neuroendocrine tumours - Details

Project Number PC0007-000
Brand Name Afinitor
Generic Name Everolimus
Strength 2.5 mg, 5 mg and 10 mg
Tumour Type Gastrointestinal
Indication Pancreatic neuroendocrine tumours
Funding Request Patients with well- or moderately differentiated neuroendocrine tumours of pancreatic origin (pNET) in patients with unresectable, locally advanced or metastatic disease.
Review Status Complete
Pre Noc Submission No
NOC Date February 2, 2012
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date February 27, 2012
Submission Deemed Complete March 5, 2012
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ March 12, 2012
Check-point meeting April 18, 2012
pERC Meeting June 21, 2012
Initial Recommendation Issued July 6, 2012
Feedback Deadline ‡ July 20, 2012
pERC Reconsideration Meeting August 16, 2012
Final Recommendation Issued August 30, 2012
Notification to Implement Issued September 17, 2012
Therapeutic Area Pancreatic Neuroendocrine Tumour
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.