Ibrance for Advanced Breast Cancer Resubmission – Details

Details

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Generic Name:
Palbociclib
Project Status:
Complete
Therapeutic Area:
Advanced breast cancer
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Ibrance Resubmission
Project Line:
Reimbursement Review
Project Number:
PC0093-000
NOC Status at Filing:
Post NOC
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
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 ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

‡ 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.