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Lynparza for Newly Diagnosed Ovarian Cancer – Details

Project Number pCODR 10174
Brand Name Lynparza
Generic Name Olaparib
Strength 100 mg and 150 mg
Tumour Type Gynecology
Indication Ovarian Cancer
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 Under Review
Pre Noc Submission Yes
NOC Date May 6, 2019
Manufacturer AstraZeneca Canada
Submitter AstraZeneca Canada
Submission Date (Target Date) April 18, 2019
Submission Deemed Complete May 3, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ May 3, 2019
Check-point meeting July 3, 2019
pERC Meeting (target date) September 19, 2019
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.