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| Project Number | pCODR 10203 |
|---|---|
| Brand Name | Zejula |
| Generic Name | Niraparib |
| Strength | 100 mg |
| Tumour Type | Gynecology |
| Indication | Ovarian Cancer |
| Funding Request | As monotherapy for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | June 27, 2019 |
| Manufacturer | GlaxoSmithKline Inc. |
| Sponsor | GlaxoSmithKline Inc. |
| Submission Date | February 7, 2020 |
| Submission Deemed Complete | February 24, 2020 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | February 24, 2020 |
| Check-point meeting | April 8, 2020 |
| pERC Meeting | June 18, 2020 |
| Initial Recommendation Issued | July 3, 2020 |
| Feedback Deadline ‡ | July 17, 2020 |
| pERC Reconsideration Meeting | August 20, 2020 |
| Final Recommendation Issued | September 3, 2020 |
| Notification to Implement Issued | September 21, 2020 |
‡ 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.
