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Ibrance for Advanced Breast Cancer – Details

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.
Submitter 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.