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Tevimbra (tislelizumab)
Australian Prescription Medicine Decision Summary
Sponsor
Active Ingredient
Tislelizumab
Date of decision
Published
Submission type
Type A (New biological medicine)
ATC codes
L01FF09 [PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors]
Decision
Approved
What was the decision based on
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.
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.
What steps were involved in the decision process
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
Date of entry onto ARTG
Black triangle scheme
Tevimbra (Tislelizumab) is to be included in the Black Triangle Scheme. The PI and CMI for Tevimbra must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
Dose forms
Concentrate for solution for infusion.
Clear to slightly opalescent, colorless to slightly yellow solution
Clear to slightly opalescent, colorless to slightly yellow solution
Strength
Each Tevimbra single dose vial contains 100 mg of tislelizumab in 10 mL solution at a concentration of 10 mg/mL
Other ingredients
Sodium citrate dihydrate, citric acid monohydrate, histidine hydrochloride monohydrate, histidine, trehalose dihydrate, polysorbate-20, and sterile water for injection
Containers
20 mL clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Pack sizes
One vial/carton.
Routes of administration
Intravenous infusion
Dosage
200 mg administered as an intravenous infusion once every 3 weeks.
Pregnancy category
D
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.
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.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
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.