| Project Number | pCODR 10091 |
|---|---|
| Brand Name | Gazyva |
| Generic Name | Obinutuzumab |
| Strength | 1000 mg vial |
| Tumour Type | Lymphoma |
| Indication | Follicular Lymphoma |
| Funding Request | In combination with chemotherapy followed by obinutuzumab monotherapy for the treatment of follicular lymphoma who have relapsed after or are refractory to a rituximab containing regimen |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | December 29, 2016 |
| Manufacturer | Hoffmann-La Roche Limited |
| Sponsor | Hoffmann-La Roche Limited |
| Submission Date | November 4, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | November 18, 2016 |
| Check-point meeting | January 18, 2017 |
| pERC Meeting | March 16, 2017 |
| Initial Recommendation Issued | March 30, 2017 |
| Feedback Deadline ‡ | April 13, 2017 |
| pERC Reconsideration Meeting | May 18, 2017 |
| Final Recommendation Issued | June 2, 2017 |
| Notification to Implement Issued | June 19, 2017 |
‡ 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.
