Eligible patients will have early access to the treatment from this month.
When combined with chemotherapy, tislelizumab has been shown to improve survival in oesophageal squamous cell carcinoma.
Earlier this month global oncology company BeiGene announced that tislelizumab has received TGA approval as a first-line treatment for oesophageal squamous cell carcinoma.
Tislelizumab, an anti-programmed cell death protein 1(PD-1) monoclonal antibody that acts by reducing binding to Fc-gamma receptors on macrophages to help immune cells identify and attack tumours, is administered to patients intravenously one every three weeks alongside their normal chemotherapy.
The TGA’s decision was made on the basis of the findings from the phase three RATIONALE-306 trial, which demonstrated the efficacy and tolerability of tislelizumab.
Specifically, adding tislelizumab to an investigator-chosen course of chemotherapy improved the median overall survival by seven months compared to chemotherapy alone (17 months versus 10 months), while also improving the median progression-free survival (7 months versus 6 months).
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The trial also found that adding tislelizumab to chemotherapy resulted in a similar safety-related outcomes to chemotherapy along. The most common adverse effects associated with tislelizumab are anaemia, decreased neutrophil count, decreased appetite, reduced white blood cell count, nausea and constipation.
Dr Senthil Sockalingham, head of medical affairs at BeiGene Asia-Pacific, welcomed the announcement.
“This new indication for tislelizumab in Australia is a significant advancement, and we are proud to introduce an early access program for eligible patients. This initiative ensures that patients in need can access this important treatment at no cost, while also providing physicians with valuable clinical experience,” they said in a statement.
Cancer Australia estimates that oesophageal cancer accounted for 1% of new cancer cases but 3% of all cancer deaths in 2022. Only one in five patients survives for at least five years after being diagnosed. The condition is more likely to affect men, and people over the age of 60.
