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| Project Number | pCODR 10094 |
|---|---|
| Brand Name | Zykadia (Resubmission) |
| Generic Name | Ceritinib |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer |
| Funding Request | For treatment as monotherapy in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | March 27, 2015 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | October 19, 2016 |
| Submission Deemed Complete | November 2, 2016 |
| Submission Type | Resubmission |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | November 2, 2016 |
| Check-point meeting | December 8, 2016 |
| pERC Meeting | February 16, 2017 |
| Initial Recommendation Issued | March 3, 2017 |
| Feedback Deadline ‡ | March 17, 2017 |
| Final Recommendation Issued | March 21, 2017 |
| Notification to Implement Issued | April 5, 2017 |
‡ 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.
