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|Project Number||pCODR 10174|
|Strength||100 mg and 150 mg|
|Funding Request||As monotherapy for the maintenance treatment of adult patients with newly diagnosed advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy, until disease progression or up to 2 years if no evidence of disease. Patients must have confirmation of BRCA mutation (identified by either germline or tumour testing) before LYNPARZA treatment is initiated.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||May 6, 2019|
|Submission Date||April 18, 2019|
|Submission Deemed Complete||May 3, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||May 3, 2019|
|Check-point meeting||July 3, 2019|
|pERC Meeting||September 19, 2019|
|Initial Recommendation Issued||October 3, 2019|
|Feedback Deadline ‡||October 18, 2019|
|pERC Reconsideration Meeting||November 21, 2019|
|Final Recommendation Issued||December 5, 2019|
|Notification to Implement Issued||December 20, 2019|
‡ 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.