BESPONSA (Pfizer Pty Ltd)
Product name
BESPONSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 working days (255)
Active ingredients
inotuzumab ozogamicin (rch)
Registration type
NCE/NBE
Indication
BESPONSA (powder of injection) is indicated for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.