| 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 | Pending |
| Pre Noc Submission | No |
| NOC Date | February 6, 2019 |
| Manufacturer | Celgene Inc. |
| Submitter | Celgene Inc. |
| Submission Date (Target Date) | April 5, 2019 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | April 22, 2019 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| Notification to Implement Issued |
‡ 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.
