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Ibrance (with Faslodex) for Advanced or Metastatic Breast Cancer – Details

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.