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Kisqali for Metastatic Breast Cancer – Details

Project Number pCODR 10112
Brand Name Kisqali
Generic Name Ribociclib
Strength 200 mg
Tumour Type Breast
Indication Advanced or Metastatic Breast Cancer
Funding Request For the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy
Review Status Under Review
Pre Noc Submission Yes
NOC Date March 2, 2018
Manufacturer Novartis Pharmaceuticals Canada Inc.
Submitter Novartis Pharmaceuticals Canada Inc.
Submission Date October 17, 2017
Submission Deemed Complete November 1, 2017
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ October 31, 2017
Check-point meeting December 12, 2017
pERC Meeting March 15, 2018
Initial Recommendation Issued (target date) March 29, 2018
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement 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.