BLINCYTO (Amgen Australia Pty Ltd)
Product name
BLINCYTO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
197 working days (255)
Active ingredients
blinatumomab
Registration type
EOI
Indication
BLINCYTO (powder for injection) is now also indicated for the treatment of minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (ALL) in patients in complete haematological remission.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.