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Kisqali for Advanced or Metastatic Breast Cancer – Details

Project Number pCODR 10194
Brand Name Kisqali
Generic Name Ribociclib
Strength 200mg
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 Notification to Implement Issued
Pre Noc Submission Yes
NOC Date February 7, 2020
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 November 18, 2019
pERC Meeting March 19, 2020
Initial Recommendation Issued April 2, 2020
Feedback Deadline ‡ April 17, 2020
pERC Reconsideration Meeting May 21, 2020
Final Recommendation Issued June 4, 2020
Notification to Implement Issued June 19, 2020

‡ 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.