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|Project Number||pCODR 10195|
|Generic Name||Ribociclib with Fulvestrant|
|Indication||Advanced or Metastatic Breast Cancer|
|Funding Request||In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial therapy or following disease progression on endocrine 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|
|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|
|Final Recommendation Issued||April 22, 2020|
|Notification to Implement Issued||May 7, 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.