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Tevimbra (tislelizumab)
Australian Prescription Medicine Decision Summary
Published
Product name
Tevimbra
Active ingredient
Tislelizumab
Submission type
Type A (New biological medicine)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
The full indications that were approved for Tevimbra are:
Oesophageal squamous cell carcinoma (OSCC)
Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic oesophageal squamous cell carcinoma after prior chemotherapy.
Non-small cell lung cancer (NSCLC)
Tevimbra in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with PD-L1 expression ≥ 50% but no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.
Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC.
How this medicine works
Tevimbra (tislelizumab) is a monoclonal antibody, a protein that can specifically block a protein called PD-1 which is found on the surface on certain types of immune system cells. Some cancers can produce proteins called PD-L1 and PD-L2 that bind to and activate PD-1. This action allows the cancer cells to survive, since PD-1 activation dampens immune cell activity, preventing them from destroying the cancer cells. By blocking PD-1, tislelizumab keeps immune cells active (it stops the "off" signal provided by PD-L1/L2), allowing the immune cells to kill the cancer cells.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology studies conducted in animal models), clinical (pharmacology, safety and efficacy trials in humans) and risk management plan information submitted by the sponsor.
Four pivotal clinical studies, one in support of each proposed indication, were submitted as well as six additional pharmacokinetic studies, a population pharmacokinetic analysis, and three exposure-response analyses.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.