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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 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.