| Project Number | pCODR 10040 |
|---|---|
| Brand Name | Treanda (in combination with rituximab) |
| Generic Name | Bendamustine hydrochloride |
| Strength | 25mg/vial and 100mg/vial |
| Tumour Type | Leukemia |
| Indication | Chronic Lymphocytic Leukemia |
| Funding Request | For the first-line treatment of patients with chronic lymphocytic leukemia in combination with rituximab |
| Review Status | Withdrawn |
| Pre Noc Submission | Yes |
| NOC Date | N/A |
| Manufacturer | Lundbeck Canada Inc. |
| Sponsor | Lundbeck Canada Inc. |
| Clarification | Lundbeck Canada Inc. has requested a voluntary withdrawal of the Bendamustine (Treanda) in combination with rituximab for CLL Submission in anticipation of new clinical information and possible resubmission. As per pCODR Procedures B3.1.6.2 b), the pCODR Secretariat has stopped the review. The pCODR Provincial Advisory Group has agreed with the manufacturer's request. |
| Submission Date | June 27, 2014 |
| Submission Deemed Complete | July 30, 2014 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | July 14, 2014 |
| 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.