ELREXFIO (Pfizer Australia Pty Ltd)
Product name
ELREXFIO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
243 (255 working days)
Active ingredients
elranatamab
Registration type
NCE/ NBE
Indication
ELREXFIO has provisional approval in Australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and have demonstrated disease progression on the last therapy.
The decision to approve this indication has been made on the basis of the overall response rate in a single arm study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration