Posted by Michael Wonder on 12 Feb 2019
Health Canada issues Notice of Compliance with Conditions for Idhifa the first oral targeted therapy for adult patients with relapsed or refractory acute myeloid leukaemia and an IDH2 mutation
11 February 2019 - Conditional approval validates Idhifa as the first and only oral, targeted inhibitor of IDH2.
Celgene today announced Health Canada has issued a Notice of Compliance with conditions for Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. Treatment with Idhifa should be initiated following confirmation of IDH2 mutation through a validated test.
The efficacy of IDHIFA in the treatment of patients with relapsed or refractory AML with an IDH2 mutation was evaluated from the phase 2 portion of the AG221-C-001 study.
