| Project Number | pCODR 10112 |
|---|---|
| Brand Name | Kisqali |
| Generic Name | Ribociclib |
| 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 | Open for Input on Submission |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Submitter | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | October 17, 2017 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | October 31, 2017 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued |
‡ 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.