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Lynparza for Ovarian Cancer (Resubmission) – Details

Project Number pCODR 10103
Brand Name Lynparza (Resubmission)
Generic Name Olaparib
Strength 50 mg capsules
Tumour Type Gynecology
Indication Ovarian Cancer
Funding Request As monotherapy maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum-based chemotherapy
Review Status Under Review
Pre Noc Submission No
NOC Date April 29, 2016
Manufacturer AstraZeneca Canada Inc.
Submitter AstraZeneca Canada Inc.
Submission Date March 17, 2017
Submission Deemed Complete March 31, 2017
Submission Type Resubmission
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ March 31, 2017
Check-point meeting May 15, 2017
pERC Meeting (target date) August 17, 2017
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.