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Zynlonta (loncastuximab tesirine)
Australian Prescription Medicine Decision Summary
Zynlonta is provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Zynlonta contains the active ingredient loncastuximab tesirine.
Published
Product name
Zynlonta
Active ingredient
Loncastuximab tesirine
Submission type
New biological entity - Type A application
Decision
Provisionally approved for registration in the Australian Register of Therapeutic Goods (ARTG)
Decision date
Registration date
What this medicine was approved for
Zynlonta was approved to treat adult patients with diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. It is specifically for DLBCL that has relapsed (come back) or is refractory (did not respond to treatment), after 2 or more previous treatments.
The approval for Zynlonta is provisional and based on the results from one study. Continued approval of this medicine depends on additional clinical trial data that must be submitted to the TGA for evaluation once the trial is completed.
How this medicine works
Zynlonta is a targeted cancer medicine that is made up of an antibody linked to a cancer-killing drug (an antibody drug conjugate). Antibodies are proteins produced by the immune system that can recognise and bind to specific sites on a target protein or cell.
The antibodies in Zynlonta are laboratory-produced and have been designed to bind to CD19, a protein on B cells, including DLBCL cancer cells. After Zynlonta binds to CD19, it enters the cell and releases the attached drug, which then kills the cancerous B cells.
Why the TGA approved or did not approve this medicine
The effectiveness of Zynlonta was assessed in a clinical study that included 145 adults with DLBCL whose cancer had returned or had not responded to treatment. All trial participants had completed at least 2 previous full courses of treatment before starting Zynlonta. Treatment continued for up to 1 year (or longer if the patient was benefiting), unless the disease worsened or side effects became unacceptable.
Key findings from clinical studies
- The overall response rate (complete and partial responses combined) was 48.3%. This means that about half of the trial participants (70 out of 145) had their cancer reduce or disappear.
- The complete response rate was 24.8%, meaning that about a quarter of the patients had no detectable cancer after treatment.
- For the 70 trial participants who responded, the benefit lasted approximately 13 months on average.
- Trial participants experienced a number of drug related side effects. These included swelling or fluid build-up in the body (including fluid around the lungs, abdomen, legs, or the heart), severe fatigue, or serious infections such as pneumonia or blood infection (sepsis).
- In some trial participants, blood tests showed changes in liver function, and sometimes treatment was delayed, the dose reduced or stopped because of these changes.
- Zynlonta could also lower blood cell counts (white cells, red cells, and platelets), which raised the risk of infection, anaemia, bruising and/or bleeding.
- In some trial participants, Zynlonta caused severe pain, severe skin or nail problems and caused an increased sensitivity to sunlight.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Zynlonta and the medicine can be registered in Australia.
More detailed information on why the TGA approved Zynlonta will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
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 CMI for Zynlonta can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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 PI for Zynlonta can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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Other resources
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For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.