Royal Perth Hospital becomes first Australian hospital licensed to manufacture TIL therapies for clinical trials
核心洞察
Royal Perth Hospital has received Therapeutic Goods Administration (搜索) (TGA) licences to manufacture both CAR T-cells and tumour-infiltrating lymphocytes (搜索) (TILs), becoming the first hospital in Australia authorised to manufacture TILs for clinical trials.
The licensing enables local manufacturing of advanced cell therapies, potentially reducing the need for Western Australian cancer patients to travel for treatment and allowing them to remain closer to family and support networks.
CAR T-cell therapy re-engineers a patient's immune cells to target certain blood cancers (搜索), while TIL therapy expands immune cells found within a tumour and is being investigated for melanoma (搜索) and other solid cancers.
Western Australia has taken a significant step toward locally manufacturing advanced cancer therapies, with Royal Perth Hospital licensed to manufacture CAR T-cells and becoming the first hospital in Australia authorised to manufacture tumour-infiltrating lymphocytes (搜索) (TILs) for clinical trials.
The Therapeutic Goods Administration (搜索) (TGA) has granted the hospital licences covering both therapies, a capability the government says could allow more Western Australian patients to access emerging treatments closer to home.
Two Advanced Cell Therapy Platforms
CAR T-cell therapy involves re-engineering a patient's immune cells to recognise and destroy cancer cells and is used for certain blood cancers (搜索). TIL therapy expands immune cells found within a patient's tumour and is being investigated for melanoma (搜索) and other solid cancers.
Royal Perth Hospital is now the only hospital in Australia authorised by the TGA to manufacture TILs and continues to be recognised internationally as a leader in CAR T-cell therapy.
Clinical Significance and Patient Access
The Western Australian Government said local manufacturing of the therapies could reduce the need for patients to travel for treatment and allow them to remain closer to their families and support networks.
"This TGA licence is a proud moment for Western Australia, confirming Royal Perth Hospital's place at the forefront of cell and gene therapy," said Medical Research Minister Stephen Dawson.
He said the new licences would provide patients with greater access to care closer to home. "Through having these new licences, WA cancer patients will have greater access to care closer to home, where they can stay closer to family and loved ones," Dawson said.
Timeline and Government Support
The government said the first clinical trial and patient treatment using locally manufactured CAR T-cell and TIL therapies are expected to begin before the end of 2026.
Dawson noted that government initiatives, including the Future Health Research and Innovation Fund and the Clinical Trials Roadmap, are supporting research and the development of new treatments.
"The Cook Labor Government will keep backing our researchers and clinicians driving these life-changing breakthroughs," Dawson said. "Through initiatives such as the Future Health Research and Innovation Fund and our Clinical Trials Roadmap, our government is supporting the development of new treatments and helping ensure Western Australians can benefit from the latest advances in health care."