| Project Number | pCODR 10150 |
|---|---|
| Brand Name | Ibrance (with Faslodex) |
| Generic Name | Palbociclib (with Fulvestrant) |
| Strength | 75 mg, 100 mg & 125 mg |
| Tumour Type | Breast |
| Indication | Advanced or Metastatic Breast Cancer |
| Funding Request | In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy, Pre- or perimenopausal women must also be treated with a luteinizing hormone releasing hormone (LHRH) agonist |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | May 19, 2017 |
| Manufacturer | Pfizer Canada Inc. |
| Sponsor | Pfizer Canada Inc. |
| Submission Date | September 28, 2018 |
| Submission Deemed Complete | October 15, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 15, 2018 |
| Check-point meeting | November 21, 2018 |
| pERC Meeting | February 21, 2019 |
| Initial Recommendation Issued | March 7, 2019 |
| Feedback Deadline ‡ | March 21, 2019 |
| pERC Reconsideration Meeting | April 18, 2019 |
| Final Recommendation Issued | May 3, 2019 |
| Notification to Implement Issued | May 21, 2019 |
‡ 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.
