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Kimmtrak
Update: the current sponsor for Kimmtrak is Medison Pharma Australia Pty Ltd. See the latest Australian Register of Therapeutic Goods (ARTG) information for Kimmtrak.
Published
Product name
Kimmtrak
Active ingredient
Tebentafusp
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Kimmtrak (tebentafusp) was approved for the following therapeutic use:
Kimmtrak is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
How this medicine works
Tebentafusp is a bispecific fusion protein, comprised of a T cell (T lymphocyte) receptor (TCR) fused to an antibody fragment with specificity for the CD3 (cluster of differentiation 3) receptor, found on polyclonal T cells. The TCR has specificity for a glycoprotein 100 (gp100) peptide (expressed preferentially in melanoma cells) presented by human leukocyte antigen A (HLA)*02:01.
In vitro, tebentafusp bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumour 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 Kimmtrak was considered favourable for the therapeutic use approved.
Sponsor