Last Updated : July 25, 2016
Details
FilesGeneric Name:
Palbociclib
Project Status:
Withdrawn
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Ibrance
Project Line:
Reimbursement Review
Project Number:
PC0068-000
Strength:
75mg, 100mg and 125mg Capsules
Tumour Type:
Breast
Indications:
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:
Withdrawn
Pre Noc Submission:
Yes
Sponsor:
Pfizer Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
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.
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.
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.
pERC Meeting:
Files
‡ 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.
Last Updated : July 25, 2016