| Project Number | pCODR 10007 |
|---|---|
| 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 | Notification to Implement Issued |
| 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 | New Indication |
| 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 |
‡ 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.
