Tevimbra (tislelizumab)
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.
This submission was evaluated under the standard prescription medicines registration process.
The following table summarises the key steps and dates for this application:
| Registration process step | Date |
|---|---|
| Dossier accepted and first round evaluation commenced | 1 August 2022 |
| First round evaluation completed | 17 February 2023 |
| Second round evaluation completed | 31 July 2023 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 9 October 2023 |
| Sponsor’s pre-Advisory Committee response | 19 March 2024 |
| ACM Meeting | 22 April 2024 |
| Registration decision (Approved) | 24 May 2024 |
| Administrative activities and registration in the ARTG completed | 30 May 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 381 |
*Statutory timeframe for standard submissions is 255 working days
Clear to slightly opalescent, colorless to slightly yellow solution
Sodium citrate dihydrate, citric acid monohydrate, histidine hydrochloride monohydrate, histidine, trehalose dihydrate, polysorbate-20, and sterile water for injection
200 mg administered as an intravenous infusion once every 3 weeks.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
There are no available data on the use of tislelizumab in pregnant women. Based on its mechanism of action, there is a potential risk that administration of tislelizumab during pregnancy may result in fetal harm.
Animal reproduction studies have not been conducted with tislelizumab. However, in mouse models of pregnancy, drugs that work through the same mechanism as tislelizumab (blockade of PD1/PDL1 signaling) has been shown to disrupt tolerance to the fetus and to result in increased fetal loss.
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.
The Tevimbra Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports (PSURs).
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.