Begin main content

Idhifa for Acute Myeloid Leukemia – Details

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 Under Review
Pre Noc Submission No
NOC Date February 6, 2019
Manufacturer Celgene Inc.
Submitter 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 (target date) August 15, 2019
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.