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| Project Number | pCODR 10112 |
|---|---|
| Brand Name | Kisqali |
| Generic Name | Ribociclib |
| Strength | 200 mg |
| Tumour Type | Breast |
| Indication | Advanced or Metastatic Breast Cancer |
| Funding Request | For the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | March 2, 2018 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | October 17, 2017 |
| Submission Deemed Complete | November 1, 2017 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | October 31, 2017 |
| Check-point meeting | December 12, 2017 |
| pERC Meeting | March 15, 2018 |
| Initial Recommendation Issued | March 29, 2018 |
| Feedback Deadline ‡ | April 13, 2018 |
| Final Recommendation Issued | April 18, 2018 |
| Notification to Implement Issued | May 3, 2018 |
‡ 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.
