A Regulatory Milestone with National Significance
In August 2026, Royal Perth Hospital achieved something no other hospital in Australia had accomplished: it became the first institution in the country licensed by the Therapeutic Goods Administration to manufacture tumour-infiltrating lymphocytes (TILs) for clinical trials. Simultaneously, it secured a licence to manufacture CAR T-cells—a therapy that re-engineers a patient’s own immune cells to recognise and destroy cancer cells.
This dual licensing marks a turning point for how advanced cancer therapies are delivered in Australia.
Understanding the Two Therapies
CAR T-cell therapy has already transformed outcomes for certain blood cancers. The process involves collecting a patient’s T cells, genetically modifying them to target specific cancer markers, and reinfusing them. TIL therapy takes a different approach: it multiplies immune cells already present inside a patient’s tumour. This approach is showing strong promise for melanoma and other solid cancers.
The ability to manufacture both therapies locally means Western Australian patients will no longer need to travel interstate or overseas to access these treatments. “Receiving care locally allows patients to stay connected to their families, communities and support networks, while benefiting from some of the most advanced cancer therapies available”.
A Broader Vision for Cancer Care Equity
The first clinical trial and patient treatment using locally manufactured CAR T-cell and TIL therapies is expected to commence before the end of 2026. Medical Research Minister Stephen Dawson described the TGA licence as “a proud moment for Western Australia,” confirming Royal Perth Hospital’s place at the forefront of cell and gene therapy.
This development is part of a broader national trend. At the Peter MacCallum Cancer Centre in Melbourne, a “precision guided” CAR T-cell therapy designed to kill solid tumours has received nearly $18 million from the Australian Government to progress to a first-in-human clinical trial. Meanwhile, HaemaLogiX has received TGA approval for its KMCAR™ T-cell therapy targeting multiple myeloma, with the first patient expected to be treated in 2026.
