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Lynparza for Ovarian Cancer (2nd line) – Details

Project Number pCODR 10081
Brand Name Lynparza
Generic Name Olaparib
Strength 50mg Capsule
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 Notification to Implement Issued
Pre Noc Submission Yes
NOC Date April 29, 2016
Manufacturer Astra Zeneca Canada Inc
Submitter Astra Zeneca Canada Inc
Submission Date April 1, 2016
Submission Deemed Complete April 8, 2016
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ April 15, 2016
Check-point meeting May 18, 2016
pERC Meeting July 21, 2016
Initial Recommendation Issued August 5, 2016
Feedback Deadline ‡ August 19, 2016
pERC Reconsideration Meeting September 15, 2016
Final Recommendation Issued September 29, 2016
Notification to Implement Issued October 17, 2016

‡ 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.