| Project Number | pCODR 10041 |
|---|---|
| Brand Name | Gazyva |
| Generic Name | Obinutuzumab |
| Strength | 1000 mg/ vial |
| Tumour Type | Leukemia |
| Indication | Chronic Lymphocytic Leukemia |
| Funding Request | In combination with chlorambucil for previously untreated chronic lymphocytic leukemia where fludarabine-based therapy is considered inappropriate |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | November 25, 2014 |
| Manufacturer | Hoffmann-La Roche Limited |
| Sponsor | Hoffmann-La Roche Limited |
| Submission Date | August 11, 2014 |
| Submission Deemed Complete | August 18, 2014 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | August 25, 2014 |
| Check-point meeting | October 1, 2014 |
| pERC Meeting | December 18, 2014 |
| Clarification | The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a November pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met. |
| Initial Recommendation Issued | January 9, 2015 |
| Feedback Deadline ‡ | January 23, 2015 |
| Final Recommendation Issued | January 27, 2015 |
| Notification to Implement Issued | February 11, 2015 |
‡ 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.
