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Ibrance for Advanced Breast Cancer Resubmission – Details

Project Number PC0093-000
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 Complete
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
Therapeutic Area Advanced breast cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.