| Project Number | pCODR 10082 |
|---|---|
| Brand Name | Imbruvica |
| Generic Name | Ibrutinib |
| Strength | 140mg Capsules |
| Tumour Type | Lymphoma |
| Indication | Waldenstrom's Macroglobulinemia |
| Funding Request | For the treatment of patients with Waldenström’s Macroglobulinemia who have received at least one prior therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | March 31, 2016 |
| Manufacturer | Janssen Canada Inc. |
| Sponsor | Janssen Canada Inc. |
| Submission Date | April 21, 2016 |
| Submission Deemed Complete | April 28, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | May 5, 2016 |
| Check-point meeting | June 23, 2016 |
| pERC Meeting | August 19, 2016 |
| Clarification | Please note that the August pERC meeting was conducted over two days. The original target date for the posting of pERC Initial Recommendation remains as September 1, 2016. |
| Initial Recommendation Issued | September 1, 2016 |
| Feedback Deadline ‡ | September 16, 2016 |
| pERC Reconsideration Meeting | October 20, 2016 |
| Final Recommendation Issued | November 3, 2016 |
| Notification to Implement Issued | November 18, 2016 |
‡ 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.
