| Project Number | pCODR 10038 |
|---|---|
| Brand Name | Arzerra |
| Generic Name | Ofatumumab |
| Strength | 20mg /vial |
| Tumour Type | Leukemia |
| Indication | Chronic Lymphocytic Leukemia |
| Funding Request | In combination with chlorambucil, for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are inappropriate for fludarabine-based therapy. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | October 2, 2014 |
| Manufacturer | GlaxoSmithKline Inc. |
| Submitter | GlaxoSmithKline Inc. |
| Clarification | A procedural review request was received from GlaxoSmithKline Inc. on February 6, 2015. As per Section 3 of the pCODR Procedural Review Guidelines, this procedural review request was submitted on the basis that pCODR failed to act in accordance with its procedures in conducting the review, as described in the pCODR Procedures, and that pERC failed to apply its deliberative framework in formulating its recommendation, as outlined in the pERC Deliberative Framework. As per Section 6 of the pCODR Procedural Review Guidelines, the procedural review request was reviewed by the President and CEO of CADTH, with advice from the pCODR Advisory Committee (PAC) Chair and Vice-Chair. It was determined on February 20, 2015, that the grounds for a procedural review request did not exist. As such, a Notification to Implement has been issued for February 23, 2015. |
| Submission Date | April 14, 2014 |
| Submission Deemed Complete | April 22, 2014 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | April 29, 2014 |
| Check-point meeting | July 16, 2014 |
| pERC Meeting | November 20, 2014 |
| Initial Recommendation Issued | December 4, 2014 |
| Feedback Deadline ‡ | December 18, 2014 |
| pERC Reconsideration Meeting | January 15, 2015 |
| Final Recommendation Issued | January 29, 2015 |
| Notification to Implement Issued | February 23, 2015 |
| Clarification | A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline. The submitter provided additional economic information, which further impacted the review timeline. |
‡ 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.
