Last Updated : December 20, 2019
Details
FilesGeneric Name:
Olaparib
Project Status:
Complete
Therapeutic Area:
Newly Diagnosed OC
Manufacturer:
AstraZeneca Canada
Brand Name:
Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0174-000
NOC Status at Filing:
Pre NOC
Strength:
100 mg and 150 mg
Tumour Type:
Gynecology
Indications:
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.
Pre Noc Submission:
Yes
Sponsor:
AstraZeneca Canada
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:
Files
‡ 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.
Last Updated : December 20, 2019