| Project Number | pCODR 10028 |
|---|---|
| Brand Name | Zytiga |
| Generic Name | Abiraterone acetate |
| Strength | 250 mg tablet |
| Tumour Type | Genitourinary |
| Indication | Metastatic Castration Resistant Prostate Cancer |
| Funding Request | For asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients after failure of ADT (have not received prior chemotherapy) |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | May 28, 2013 |
| Manufacturer | Janssen Inc. |
| Submitter | Janssen Inc. |
| Submission Date | March 28, 2013 |
| Submission Deemed Complete | April 8, 2013 |
| Submission Type | New Indication |
| Prioritization Requested | No |
| Stakeholder Input Deadline ‡ | April 15, 2013 |
| Check-point meeting | June 24, 2013 |
| pERC Meeting | September 19, 2013 |
| Initial Recommendation Issued | October 3, 2013 |
| Feedback Deadline ‡ | October 18, 2013 |
| Final Recommendation Issued | October 22, 2013 |
| Notification to Implement Issued | November 6, 2013 |
‡ 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.
