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Tecvayli
Published
Product name
Tecvayli
Active ingredient
Teclistamab
Submission type
New Biological Entity
Decision
Approved for provisional registration.
Decision date
Registration date
What this medicine was approved for
Tecvayli (teclistamab) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
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.
How this medicine works
Teclistamab is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. In vitro, teclistamab activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Tecvayli was considered favourable for the therapeutic use approved.
Sponsor