Idhifa for Acute Myeloid Leukemia – Details


( Last Updated : November 15, 2019)
Generic Name:
Enasidenib
Project Status:
Complete
Therapeutic Area:
Acute myeloid leukemia (AML)
Manufacturer:
Celgene Inc.
Brand Name:
Idhifa
Project Line:
Reimbursement Review
Project Number:
PC0144-000
NOC Date:

Details


Strength:
50 mg and 100 mg
Tumour Type:
Leukemia
Indications:
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:
Complete
Sponsor:
Celgene Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
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
pERC Meeting:
Final Recommendation Issued:

Files

‡ 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.