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| Project Number | pCODR 10062 |
|---|---|
| Brand Name | Zykadia |
| Generic Name | Ceritinib |
| Strength | 150 mg capsule |
| Tumour Type | Lung |
| Indication | Metastatic 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 Inc. |
| Sponsor | Novartis Pharmaceuticals Inc. |
| Submission Date | June 5, 2015 |
| Submission Deemed Complete | June 12, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | June 19, 2015 |
| Check-point meeting | July 29, 2015 |
| pERC Meeting | September 17, 2015 |
| Initial Recommendation Issued | October 1, 2015 |
| Feedback Deadline ‡ | October 16, 2015 |
| pERC Reconsideration Meeting | November 19, 2015 |
| Final Recommendation Issued | December 3, 2015 |
| Notification to Implement Issued | December 18, 2015 |
‡ 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.
