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Kisqali for Advanced or Metastatic Breast Cancer – Details

Project Number pCODR 10194
Brand Name Kisqali
Generic Name Ribociclib
Tumour Type Breast
Indication Advanced or Metastatic Breast Cancer
Funding Request In combination with an aromatase inhibitor (AI) and a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of pre/peri- menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date August 26, 2019
Submission Deemed Complete September 10, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ September 10, 2019
Check-point meeting (target date) November 18, 2019
pERC Meeting (target date)
Initial Recommendation Issued (target date)
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.