| Project Number | pCODR 10093 |
|---|---|
| Brand Name | Ibrance Resubmission |
| 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 | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | March 16, 2016 |
| Manufacturer | Pfizer Canada Inc. |
| Sponsor | Pfizer Canada Inc. |
| Submission Date | June 10, 2016 |
| Submission Deemed Complete | June 24, 2016 |
| Submission Type | Resubmission |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | June 24, 2016 |
| Check-point meeting | August 17, 2016 |
| pERC Meeting | October 20, 2016 |
| Initial Recommendation Issued | November 3, 2016 |
| Feedback Deadline ‡ | November 17, 2016 |
| Final Recommendation Issued | November 21, 2016 |
| Notification to Implement Issued | December 6, 2016 |
‡ 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.
