| Project Number | pCODR 10166 |
|---|---|
| Brand Name | Zytiga |
| Generic Name | Abiraterone |
| Strength | 250 mg & 500 mg |
| Tumour Type | Genitourinary |
| Indication | Prostate Cancer |
| Funding Request | Newly diagnosed with metastatic prostate cancer without small-cell histologic features (may have received prior surgery or radiation therapy for local disease or palliative therapy); Less than 3 months of androgen deprivation therapy for metastatic disease (may have received prior adjuvant/neoadjuvant hormone therapy); Eligible for abiraterone therapy |
| Review Status | Withdrawn |
| Clarification | BC Cancer Agency has requested a voluntary withdrawal of the pCODR 10166 Abiraterone (Zytiga) for PC Submission. As per pCODR Procedures B3.1.6.2 b), the pCODR Provincial Advisory Group has agreed to the request to withdraw and decided to not continue the review as a PAG Submission. |
| Pre Noc Submission | No |
| NOC Date | February 15, 2018 |
| Manufacturer | Janssen Inc. |
| Submitter | BC Cancer Agency |
| Submission Date | February 25, 2019 |
| Submission Deemed Complete | March 11, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | March 11, 2019 |
| 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.