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Health Canada Health products

IDHIFA (enasidenib mesylate) – Market Withdrawal and Continued Access

Issued June 8, 2023
Issue
IDHIFA failed to demonstrate improved OS in adult patients with late stage AML and an IDH2 mutation versus conventional care regimens in a Phase 3 confirmatory study evaluating efficacy and safety. Do not initiate IDHIFA in new patients. IDHIFA is available through Health Canada’s SAP for patients who require continued treatment.
Hazard description
New safety information - Product withdrawal
Product
Product name
IDHIFA (enasidenib)
Reference
ID
RA-73771