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| Project Number | pCODR 10196 |
|---|---|
| Brand Name | Nubeqa |
| Generic Name | Darolutamide |
| Strength | 300 mg |
| Tumour Type | Genitourinary |
| Indication | Non-Metastatic Castration Resistant Prostate Cancer |
| Funding Request | In combination with androgen depravation therapy (ADT), for the treatment of patients with non-metastatic castration resistant prostate cancer who are at high risk of developing metastases (high risk defined as prostate-specific antigen doubling time ≤ 10 months) during continuous ADT, and have a good Eastern Cooperative Oncology Group (ECOG) performance status |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | February 20, 2020 |
| Manufacturer | Bayer Inc. |
| Sponsor | Bayer Inc. |
| Submission Date | August 27, 2019 |
| Submission Deemed Complete | September 11, 2019 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | September 11, 2019 |
| Check-point meeting | November 12, 2019 |
| pERC Meeting | March 19, 2020 |
| Initial Recommendation Issued | April 2, 2020 |
| Feedback Deadline ‡ | April 17, 2020 |
| Final Recommendation Issued | April 22, 2020 |
| Notification to Implement Issued | May 7, 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.
