| Project Number | pCODR 10149 |
|---|---|
| Brand Name | Xtandi |
| Generic Name | Enzalutamide |
| Strength | 40 mg |
| Tumour Type | Genitourinary |
| Indication | Non-metastatic castration-resistant prostate cancer |
| Funding Request | High risk, non-metastatic castration-resistant prostate cancer |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | December 20, 2018 |
| Manufacturer | Astellas Pharma Canada, Inc. |
| Sponsor | Astellas Pharma Canada, Inc. |
| Submission Date | September 24, 2018 |
| Submission Deemed Complete | October 9, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 9, 2018 |
| Check-point meeting | November 20, 2018 |
| pERC Meeting | February 21, 2019 |
| Initial Recommendation Issued | March 7, 2019 |
| Feedback Deadline ‡ | March 21, 2019 |
| Final Recommendation Issued | March 26, 2019 |
| Notification to Implement Issued | April 10, 2019 |
‡ 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.
