| 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.
