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Lynparza for Ovarian Cancer (Resubmission) – Details

Project Number PC0103-000
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 Complete
Pre Noc Submission No
NOC Date April 29, 2016
Manufacturer AstraZeneca Canada Inc.
Sponsor 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 August 17, 2017
Initial Recommendation Issued August 31, 2017
Feedback Deadline ‡ September 15, 2017
Final Recommendation Issued September 20, 2017
Notification to Implement Issued October 5, 2017
Therapeutic Area Ovarian Cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.