| 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 | Pending |
| Pre Noc Submission | No |
| NOC Date | June 27, 2019 |
| Manufacturer | GlaxoSmithKline Inc. |
| Sponsor | GlaxoSmithKline Inc. |
| Submission Date (Target Date) | February 7, 2020 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | February 24, 2020 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued |
‡ 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.
