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| Project Number | pCODR 10057 |
|---|---|
| Brand Name | Zydelig |
| Generic Name | Idelalisib |
| Strength | 100mg and 150mg tablets |
| Tumour Type | Leukemia |
| Indication | Chronic Lymphocytic Leukemia |
| Funding Request | In combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) |
| 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 7, 2015 |
| Submission Deemed Complete | April 14, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | April 21, 2015 |
| Check-point meeting | May 28, 2015 |
| pERC Meeting | July 16, 2015 |
| Initial Recommendation Issued | July 30, 2015 |
| Feedback Deadline ‡ | August 14, 2015 |
| Final Recommendation Issued | August 18, 2015 |
| Notification to Implement Issued | September 2, 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.
