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| Project Number | pCODR 10133 |
|---|---|
| Brand Name | Erleada |
| Generic Name | Apalutamide |
| Strength | 60 mg |
| Tumour Type | Genitourinary |
| Indication | Castrate Resistant Prostate Cancer |
| Funding Request | non-metastatic castrate resistant prostate cancer (nm-CRPC) |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | July 3, 2018 |
| Manufacturer | Janssen Inc. |
| Sponsor | Janssen Inc. |
| Submission Date | April 16, 2018 |
| Submission Deemed Complete | May 1, 2018 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | April 30, 2018 |
| Check-point meeting | June 12, 2018 |
| pERC Meeting | August 16, 2018 |
| Initial Recommendation Issued | August 30, 2018 |
| Feedback Deadline ‡ | September 14, 2018 |
| pERC Reconsideration Meeting | October 18, 2018 |
| Final Recommendation Issued | November 1, 2018 |
| Notification to Implement Issued | November 16, 2018 |
‡ 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.
