TECVAYLI (Janssen-Cilag Pty Ltd)
Product name
TECVAYLI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
209 (255 working days)
Active ingredients
teclistamab
Registration type
NCE/NBE
Indication
TECVAYLI as monotherapy 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 three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
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