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| Project Number | pCODR 10083 |
|---|---|
| Brand Name | Afinitor |
| Generic Name | Everolimus |
| Strength | 2.5 mg, 5mg, 7.5mg and 10 mg tablets |
| Tumour Type | Endocrine |
| Indication | Neuroendocrine tumours of Gastrointestinal or Lung origin |
| Funding Request | For the treatment of unresectable, locally advanced or metastatic, well differentiated non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults with progressive disease |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | May 17, 2016 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | May 30, 2016 |
| Submission Deemed Complete | June 6, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | June 13, 2016 |
| Check-point meeting | July 20, 2016 |
| pERC Meeting | September 15, 2016 |
| Initial Recommendation Issued | September 29, 2016 |
| Feedback Deadline ‡ | October 14, 2016 |
| pERC Reconsideration Meeting | November 17, 2016 |
| Final Recommendation Issued | December 1, 2016 |
| Notification to Implement Issued | December 16, 2016 |
‡ 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.
