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| Project Number | pCODR 10068 |
|---|---|
| Brand Name | Ibrance |
| Generic Name | Palbociclib |
| Strength | 75mg, 100mg and 125mg Capsules |
| Tumour Type | Breast |
| Indication | Advanced Breast Cancer |
| Funding Request | In combination with letrozole, for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease |
| Review Status | Suspended |
| Pre Noc Submission | Yes |
| NOC Date | March 16, 2016 |
| Manufacturer | Pfizer Canada Inc. |
| Sponsor | Pfizer Canada Inc. |
| Submission Date | November 11, 2015 |
| Submission Deemed Complete | November 18, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | November 25, 2015 |
| Check-point meeting | January 12, 2016 |
| pERC Meeting | April 21, 2016 |
| Clarification | The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission were not available to complete the submission for a March pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. |
| Initial Recommendation Issued | May 5, 2016 |
| Feedback Deadline ‡ | May 19, 2016 |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued | |
| Clarification | In accordance with the pCODR Procedures, the pCODR program has suspended all work on this original Submission. The manufacturer, Pfizer Canada Inc. has resubmitted to pCODR for palbociclib (Ibrance) for advanced breast cancer with new information before a Final Recommendation has been issued. Please see the palbociclib (Ibrance) for advanced breast cancer Resubmission Details page for more information. |
‡ 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.
