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Jemperli
Published
Product name
Jemperli
Active ingredient
Dostarlimab
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Jemperli (dostarlimab) was approved for the following therapeutic use:
Jemperli is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
This medicine and indication have provisional approval, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
How this medicine works
Dostarlimab is an anti programmed cell death protein 1 (PD 1) immunoglobulin G4 (IgG4) humanised monoclonal antibody (mAb), derived from a stable Chinese hamster ovary (CHO) cell line. Binding of the PD 1 ligands, PD L1 and PD L2, to the PD 1 receptor found on T cells inhibits T cell proliferation and cytokine production. Upregulation of PD 1 ligands occur in some tumours and signalling through this pathway can contribute to inhibition of active T cell immune surveillance of tumours. Dostarlimab is a humanised mAb of IgG4 isotype that binds to PD 1, resulting in inhibition of binding to PD L1 and PD L2, releasing inhibition of PD 1 pathway mediated immune response, including the antitumour immune response. In syngeneic mouse tumour models, blocking PD 1 activity resulted in decreased tumour growth.
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 Jemperli was considered favourable for the therapeutic use approved.