| Project Number | pCODR 10075 |
|---|---|
| Brand Name | Zydelig |
| Generic Name | Idelalisib |
| Strength | 100mg & 150mg Tablets |
| Tumour Type | Lymphoma |
| Indication | Follicular Lymphoma |
| Funding Request | For the treatment of patients with follicular lymphoma who have received at least two prior systemic therapies and are refractory to both rituximab and an alkylating agent |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | March 27, 2015 |
| Manufacturer | Gilead Sciences, Inc. |
| Sponsor | Gilead Sciences, Inc. |
| Submission Date | April 12, 2016 |
| Submission Deemed Complete | April 19, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | April 26, 2016 |
| Check-point meeting | May 26, 2016 |
| pERC Meeting | July 21, 2016 |
| Initial Recommendation Issued | August 5, 2016 |
| Feedback Deadline ‡ | August 19, 2016 |
| pERC Reconsideration Meeting | September 15, 2016 |
| Final Recommendation Issued | September 29, 2016 |
| Notification to Implement Issued | October 17, 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.
