| Project Number | pCODR 10144 |
|---|---|
| Brand Name | Idhifa |
| Generic Name | Enasidenib |
| Strength | 50 mg and 100 mg |
| Tumour Type | Leukemia |
| Indication | Acute Myeloid Leukemia (AML) |
| Funding Request | For the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | February 6, 2019 |
| Manufacturer | Celgene Inc. |
| Sponsor | Celgene Inc. |
| Submission Date | April 5, 2019 |
| Submission Deemed Complete | April 22, 2019 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | April 22, 2019 |
| Check-point meeting | June 12, 2019 |
| pERC Meeting | August 15, 2019 |
| Initial Recommendation Issued | August 29, 2019 |
| Feedback Deadline ‡ | September 13, 2019 |
| pERC Reconsideration Meeting | October 17, 2019 |
| Final Recommendation Issued | October 31, 2019 |
| Notification to Implement Issued | November 15, 2019 |
‡ 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.
