IDHIFA (Celgene Pty Ltd)
Product name
IDHIFA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
220 working days (255)
Active ingredients
enasidenib
Registration type
NCE/NBE
Indication
IDHIFA (film-coated tablet) has Provisional Approval in Australia for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia who are ineligible for haematopoietic stem cell transplant, and who have an isocitrate dehydrogenase-2 (IDH2) mutation confirmed by a validated diagnostic test.
The decision to approve this indication has been made on the basis of preliminary clinical data from a Phase 1/2 clinical trial with a primary endpoint of overall response rate. An improvement in OS or PFS has not been established. The sponsor is required to submit further clinical data to confirm the efficacy and safety of the medicine.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.